FDA Product Code
FDA Product Code FEB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 58 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261791 | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor | Steris | 2026-10-02 | Traditional | PDF ↗ |
| K241168 | System 83 Revolve Endoscope Washer/Disinfector | Wassenburg Medical, Inc. | 2024-12-19 | Traditional | PDF ↗ |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | STERIS Corporation | 2024-12-02 | Special | PDF ↗ |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing System | STERIS Corporation | 2023-06-30 | Traditional | PDF ↗ |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | Medivators, Inc. | 2022-01-14 | Special | PDF ↗ |
| K201920 | Endoscope Reprocessor OER-Elite | Olympus Medical Systems Corp. | 2020-09-01 | Special | PDF ↗ |
| K173590 | System 83 Plus Washer/Disinfector | Custom Ultrasonics, Inc. | 2020-03-30 | Traditional | PDF ↗ |
| K190969 | ENDOSCOPE REPROCESSOR OER-Elite | Olympus Medical Systems Corp. | 2019-07-09 | Traditional | PDF ↗ |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | Advanced Sterilization Products (Asp) | 2019-04-23 | Traditional | PDF ↗ |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System | STERIS Corporation | 2018-12-14 | Traditional | PDF ↗ |
| K172677 | Advantage Plus Pass-Thru | Medivators, Inc. | 2017-12-19 | Traditional | PDF ↗ |
| K162120 | Scope-Assist Flushing Sink | Custom Ultrasonics, Inc. | 2017-04-28 | Traditional | PDF ↗ |
| K162128 | Scope Buddy Plus Endoscope Flushing Aid | Medivators, Inc. | 2016-12-21 | Traditional | PDF ↗ |
| K152189 | EVOTECH ECR | Advanced Sterilization Products (Asp) | 2016-07-20 | Traditional | PDF ↗ |
| K140977 | EVOTECH ECR | Advanced Sterilization Products | 2014-12-22 | Traditional | PDF ↗ |
| K122172 | SYSTEM 83 PLUS | Custom Ultrasonics | 2013-01-25 | Special | PDF ↗ |
| K120357 | ENDOSCOPE REPROCESSOR OER-MINI | Olympus Medical Systems Corp. | 2012-12-20 | Traditional | PDF ↗ |
| K101158 | LIC INSTRUMENT PROCESSING SYSTEM | Langford IC Systems, Inc. | 2011-05-06 | Traditional | PDF ↗ |
| K103264 | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO | Olympus Medical Systems Corporation | 2011-02-23 | Traditional | PDF ↗ |
| K102996 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR | Medivators Reprocessing Systems | 2011-01-13 | Traditional | PDF ↗ |
| K092387 | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM | Minntech Corp. | 2010-04-05 | Traditional | PDF ↗ |
| K093106 | ENDOSCOPE REPROCESSOR OER-PRO | Olympus Medical Systems Corporation | 2010-02-12 | Traditional | PDF ↗ |
| K082988 | MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT | Medivators Reprocessing Systems | 2009-02-13 | Traditional | PDF ↗ |
| K082392 | EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR | Advanced Sterilization Products | 2008-11-13 | Special | PDF ↗ |
| K063876 | MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING | Medivators Reprocessing Systems | 2007-06-14 | Traditional | PDF ↗ |
| K061430 | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR | Custom Ultrasonics | 2007-01-12 | Traditional | PDF ↗ |
| K061899 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM | Advanced Sterilization Products | 2006-10-26 | Traditional | PDF ↗ |
| K060458 | MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR | Langford IC Systems, Inc. | 2006-10-12 | Traditional | PDF ↗ |
| K040883 | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM | Advanced Sterilization Products | 2005-03-15 | Traditional | PDF ↗ |
| K012309 | RIWO SYSTEM TRAYS | Richard Wolf Medical Instruments Corp. | 2001-10-19 | Traditional | PDF ↗ |
| K000216 | PSK ENDOSCOPE CLEANING SYSTEM | Psk Connectors Pty, Ltd. | 2000-05-09 | Traditional | PDF ↗ |
| K973558 | VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) | Ultracell Medical Technologies, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K964871 | BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS | Biosearch Medical Products, Inc. | 1997-03-03 | Traditional | PDF ↗ |
| K961607 | VIRAPUMP II (MODELS AND MODEL M) | Viatro, Corp. | 1996-12-06 | Traditional | PDF ↗ |
| K954745 | MILL-ROSE RIGID SCOPE CLEANING BRUSHES | Mill-Rose Laboratory | 1995-11-27 | Traditional | PDF ↗ |
| K915402 | EW-10 AND EW-20 | Olympus Corp. | 1995-06-23 | Traditional | PDF ↗ |
| K944776 | CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT | Blue Planet Industries, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K944249 | AUTO SUTURE* ANTI-FOG DEVICE** | United States Surgical, A Division of Tyco Healthc | 1994-09-20 | Traditional | PDF ↗ |
| K941648 | BLUE PLANET LENS FOG REDUCTION & CLEANING KIT | Blue Planet Industries, Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K941134 | EMC2 LENS FOG REDUCTION SOLUTION & CLEANING KIT | H & C Chemical, Inc. | 1994-05-16 | Traditional | PDF ↗ |
| K914524 | FLUID PUMP, CP #3 | United States Endoscopy Group, Inc. | 1994-03-09 | Traditional | PDF ↗ |
| K914145 | DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES | Medivators, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K915620 | ENDOWASH | Novar Medical Industries | 1993-12-02 | Traditional | PDF ↗ |
| K933354 | HOBBS MEDICAL CLEANING BRUSH | Hobbs Medical, Inc. | 1993-10-28 | Traditional | PDF ↗ |
| K932930 | CANDELA MINIBRUSH | Candela Laser Corp. | 1993-10-05 | Traditional | PDF ↗ |
| K924135 | FLEXIBLE URETERONEPHROSOCOPE | Applied Medical Resources | 1993-04-14 | Traditional | PDF ↗ |
| K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 | Keymed, Inc. | 1993-03-29 | Traditional | PDF ↗ |
| K924655 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) | Cox Medical Ent., Inc. | 1992-12-15 | Traditional | PDF ↗ |
| K924103 | CLEANING BRUSH | United States Endoscopy Group, Inc. | 1992-11-16 | Traditional | PDF ↗ |
| K923687 | ONE DIRECTIONAL CLEANING BRUSH | Endoscopy Support Services, Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K923672 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH | Cox Medical Ent., Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K914442 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH | Cox Medical Ent., Inc. | 1991-10-25 | Traditional | PDF ↗ |
| K901439 | DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN | Telemed Systems, Inc. | 1990-06-11 | Traditional | PDF ↗ |
| K850268 | SPARCO SCOPE GUARD | Sparco, Inc. | 1985-04-15 | Traditional | PDF ↗ |
| K840208 | CODE 17-ENDOSCOPE DEODORANT | Knox Laboratories | 1984-07-19 | Traditional | PDF ↗ |
| K830026 | FIBERSCOPE DISINFECTANT IRRIGATOR | Keymed, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K820152 | KEY MED LEEDS ENDOSCOPE DISINFECTOR | Keymed, Inc. | 1982-01-29 | Traditional | PDF ↗ |
| K810818 | KEY-MED FIBRESCOPE DISINFECTION TROLLEY | Keymed, Inc. | 1981-04-08 | Traditional | PDF ↗ |
Product code FEB · Class II · Gastroenterology, Urology. Data: openFDA.