FDA Product Code
FDA Product Code ETB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3450
510(k) Clearances — 74 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 | Special | PDF ↗ |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 | Special | PDF ↗ |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 | Traditional | PDF ↗ |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 | Traditional | PDF ↗ |
| K130512 | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS | Heinz Kurz GmbH Medizintechnik | 2013-12-02 | Traditional | PDF ↗ |
| K112616 | NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS | Heinz Kurz GmbH Medizintechnik | 2013-02-08 | Traditional | PDF ↗ |
| K080070 | K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES | Grace Medical, Inc. | 2008-04-17 | Traditional | PDF ↗ |
| K063374 | NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE | Grace Medical, Inc. | 2006-12-06 | Traditional | PDF ↗ |
| K061853 | GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES | Grace Medical, Inc. | 2006-08-18 | Traditional | PDF ↗ |
| K060518 | PARTIAL OSSICULAR REPLACEMENT PROSTHESES | Grace Medical, Inc. | 2006-06-28 | Traditional | PDF ↗ |
| K033554 | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS | Gyrus Ent LLC | 2003-11-24 | Traditional | PDF ↗ |
| K021479 | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 | Heinz Kurz GmbH Medizintechnik | 2002-05-21 | Special | PDF ↗ |
| K013573 | CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 | Heinz Kurz GmbH Medizintechnik | 2001-11-09 | Special | PDF ↗ |
| K010442 | KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 | Heinz Kurz | 2001-03-08 | Special | PDF ↗ |
| K003214 | SMITH & NEPHEW PISTONS | Gyrus Ent LLC | 2000-10-31 | Traditional | PDF ↗ |
| K002737 | SMITH & NEPHEW PORPS & TORPS | Gyrus Ent LLC | 2000-10-12 | Traditional | PDF ↗ |
| K002897 | TITANIUM MIDDLE EAR PROSTHESES | Xomed, Inc. | 2000-10-11 | Traditional | PDF ↗ |
| K002464 | SMITH & NEPHEW OFF-CENTERED PORP | Gyrus Ent LLC | 2000-08-29 | Traditional | PDF ↗ |
| K002221 | KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 | Heinz Kurz GmbH Medizintechnik | 2000-08-09 | Traditional | PDF ↗ |
| K001142 | AUDIO TECHNOLOGIES S:R.1 | Audio Technologies S.R.L. | 2000-06-23 | Traditional | PDF ↗ |
| K000858 | WEHRS INCUS-STAPES | Gyrus Ent LLC | 2000-04-03 | Traditional | PDF ↗ |
| K000256 | CAP PORP, CAP TORP | Gyrus Ent LLC | 2000-02-11 | Traditional | PDF ↗ |
| K993234 | MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS | Micromedics, Inc. | 1999-11-10 | Traditional | PDF ↗ |
| K992839 | SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE | Heinz Kurz GmbH Medizintechnik | 1999-09-16 | Traditional | PDF ↗ |
| K991394 | STAPES PROSTHESES | Grace Medical, Inc. | 1999-05-18 | Special | PDF ↗ |
| K990923 | TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 | Heinz Kurz | 1999-03-31 | Special | PDF ↗ |
| K981045 | EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS | Exmoor Plastics , Ltd. | 1998-05-20 | Traditional | PDF ↗ |
| K974365 | MILLS INCUS HA SLEEVE | Exmoor Plastics , Ltd. | 1998-01-22 | Traditional | PDF ↗ |
| K973356 | K-PISTON WITH BAND HOOK /ANGULAR PISTON | Heinz Kurz | 1997-11-21 | Traditional | PDF ↗ |
| K972815 | PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT | Grace Medical, Inc. | 1997-10-08 | Traditional | PDF ↗ |
| K972737 | CAUSSE PISTON | Mednet Locator, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K972734 | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) | Mednet Locator, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K972492 | BELL PROSTHESIS (PARTIAL) | Heinz Kurz | 1997-08-04 | Traditional | PDF ↗ |
| K964909 | ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS | Xomed, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K962564 | RICHARDS TOTAL/PARTIAL PROSTHESIS | Gyrus Ent LLC | 1997-01-22 | Traditional | PDF ↗ |
| K964798 | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS | Anthony D. Prescott | 1997-01-02 | Traditional | PDF ↗ |
| K963752 | PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS | Grace Medical, Inc. | 1996-10-10 | Traditional | PDF ↗ |
| K945105 | POLY/PLATINUM WIRE PISTON | Micromed Development Corp. | 1996-05-14 | Traditional | PDF ↗ |
| K955613 | MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS | Misten Medical Corp. | 1995-12-22 | Traditional | PDF ↗ |
| K954517 | TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT | Trebay Medical Corp. | 1995-10-27 | Traditional | PDF ↗ |
| K952481 | RICHARDS PORP | Smith & Nephew Richards, Inc. | 1995-06-16 | Traditional | PDF ↗ |
| K950984 | HAPES MALLEABLE INCUS STAPES | Smith & Nephew Richards, Inc. | 1995-03-15 | Traditional | PDF ↗ |
| K950886 | HAPEX PORP | Smith & Nephew Richards, Inc. | 1995-03-15 | Traditional | PDF ↗ |
| K950887 | HAPEX INCUS | Smith & Nephew Richards, Inc. | 1995-03-15 | Traditional | PDF ↗ |
| K950885 | HAPEX MALLEABLE PORP | Smith & Nephew Richards, Inc. | 1995-03-15 | Traditional | PDF ↗ |
| K945104 | MICROMED PARTIAL REGULAR AND PARTIAL OFFSET | Micromed Development Corp. | 1994-11-22 | Traditional | PDF ↗ |
| K945108 | POLY PISTON | Micromed Development Corp. | 1994-11-22 | Traditional | PDF ↗ |
| K945107 | POLY-WIRE PISTON | Micromed Development Corp. | 1994-11-22 | Traditional | PDF ↗ |
| K925443 | INCUDOSTAPEDIAL JOINT | Smith & Nephew Richards, Inc. | 1993-03-08 | Traditional | PDF ↗ |
| K915120 | TEF/PLATINUM PISTON | River Medical, Inc. | 1991-12-27 | Traditional | PDF ↗ |
| K915121 | TEF/WIRE PISTON | River Medical, Inc. | 1991-12-23 | Traditional | PDF ↗ |
| K913287 | H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET | River Medical, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K913285 | PTFE PISTON | River Medical, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K910685 | WEHRS INCUS AND INCUS-STAPES PROSTHESES | Smith & Nephew Richards, Inc. | 1991-12-04 | Traditional | PDF ↗ |
| K913619 | CERAVITAL MIDDLE EAR IMPLANT | Friedrichsfeld Medizintechnik AG | 1991-10-15 | Traditional | PDF ↗ |
| K895814 | MICROTEK PISTON & WIRE PROSTHESES | Microbio-Medics, Inc. | 1989-12-26 | Traditional | PDF ↗ |
| K893134 | APACERAM OSSICULAR PROSTHESIS | Asahi Optical Co. C/O Rosati Associates, P.C. | 1989-08-03 | Traditional | PDF ↗ |
| K883727 | BUCKET PROSTHESIS PORP | Treace Medical, Inc. | 1989-01-13 | Traditional | PDF ↗ |
| K872112 | XOMED PLATINUM WIRE TEFLON PISTION | Xomed, Inc. | 1987-07-02 | Traditional | PDF ↗ |
| K870766 | PROSTHESIS WIRE | Treace Medical, Inc. | 1987-04-15 | Traditional | PDF ↗ |
| K861369 | INCUS/STAPES PROSTHESIS | Richards Medical Co., Inc. | 1986-07-14 | Traditional | PDF ↗ |
| K860460 | MICROTEK STAINLESS STEEL PISTON | Microtek Medical, Inc. | 1986-07-11 | Traditional | PDF ↗ |
| K844961 | INCUS PROSTHESIS | Richards Medical Co., Inc. | 1985-02-26 | Traditional | PDF ↗ |
| K841353 | CAUSSE SPONGE BOAT | Treace Medical, Inc. | 1984-07-06 | Traditional | PDF ↗ |
| K832540 | DRUMTO STAPES PROSTHESIS | Humboldt Products | 1984-01-03 | Traditional | PDF ↗ |
| K823483 | STAINLESS STEEL PISTONS | Humboldt Products | 1982-12-09 | Traditional | PDF ↗ |
| K823440 | MCGEE MODIFIED STAINLESS STEEL PISTON | Treace Medical, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K823429 | FISCH MODIFIED TEF-WIRE PISTON | Treace Medical, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K823439 | CAUSSE TEF-PISTON | Treace Medical, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K802873 | SHEA LOCKING BAIL PROSTHESIS | Richard'S Medical Equip., Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K802431 | SCHURING OSSICLE CUP & COLUMELLA PROSTH. | Richard'S Medical Equip., Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K760437 | CAUSSE MODIFIED TEFLON PISTON, OTOLOGY | Richard'S Medical Equip., Inc. | 1976-10-05 | Traditional | PDF ↗ |
| K760434 | TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY | Richard'S Medical Equip., Inc. | 1976-10-05 | Traditional | PDF ↗ |
| K760435 | PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT | Richard'S Medical Equip., Inc. | 1976-09-27 | Traditional | PDF ↗ |
Product code ETB · Class II · Ear, Nose, Throat. Data: openFDA.