FDA Product Code
FDA Product Code HIG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1700
510(k) Clearances — 57 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261706 | Endomat Select (UP220) | KARL STORZ SE & CO. KG | 2026-07-16 | Traditional | PDF ↗ |
| K251273 | Asurys Fluid Management System | Boston Scientific Corporation | 2026-03-27 | Traditional | PDF ↗ |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Hologic, Inc. | 2024-07-25 | Traditional | PDF ↗ |
| K210628 | X-FLO Fluid Management System | Thermedx, LLC | 2021-11-04 | Traditional | PDF ↗ |
| K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020-07-22 | Special | PDF ↗ |
| K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018-10-31 | Traditional | PDF ↗ |
| K180825 | Fluent Fluid Management System | Hologic, Inc. | 2018-08-03 | Traditional | PDF ↗ |
| K173489 | GYN-Pump PH304 | W.O.M. World of Medicine GmbH | 2018-03-28 | Traditional | PDF ↗ |
| K172040 | Aquilex Fluid Control System AQL-100S | W.O.M. World of Medicine GmbH | 2018-02-05 | Special | PDF ↗ |
| K172048 | FluidSmart | Thermedx, LLC | 2017-09-05 | Special | PDF ↗ |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | Thermedx, LLC | 2014-06-20 | Traditional | PDF ↗ |
| K123732 | HYSTEROSCOPY PUMP HM6 | W.O.M. World of Medicine AG | 2013-04-04 | Special | PDF ↗ |
| K112642 | AQUILEX FLUID CONTROL SYSTEM H112 | W.O.M. World of Medicine AG | 2012-02-06 | Traditional | PDF ↗ |
| K110852 | DOLPHIN 3 FLUID MANAGEMENT SYSTEM | Gyrus Acmi, Inc. | 2011-07-19 | Traditional | PDF ↗ |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | Thermedx, LLC | 2010-07-23 | Traditional | PDF ↗ |
| K031616 | IUR FLUID MANAGEMENT SYSTEM | W.O.M. World of Medicine AG | 2003-08-13 | Special | PDF ↗ |
| K031213 | AQUASENS FLUID MONITORING SYSTEM | Davol, Inc. | 2003-04-30 | Traditional | PDF ↗ |
| K022449 | HYSTEREOSCOPY PUMP HM4 | W.O.M. World of Medicine AG | 2003-04-10 | Traditional | PDF ↗ |
| K011876 | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 | Circon Video | 2002-01-08 | Traditional | PDF ↗ |
| K011069 | AQUASENS FLUID MONITORING SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 2001-08-16 | Traditional | PDF ↗ |
| K000806 | KARL STORZ HYSTEROMAT II | KARL STORZ Endoscopy-America, Inc. | 2000-11-30 | Traditional | PDF ↗ |
| K991799 | DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO | Davol Inc., Sub. C. R. Bard, Inc. | 1999-09-13 | Traditional | PDF ↗ |
| K982867 | HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 | Davol Inc., Sub. C. R. Bard, Inc. | 1999-02-19 | Traditional | PDF ↗ |
| K983889 | HYS-SURGIFLATOR 150P | W.O.M. World of Medicine GmbH | 1999-01-14 | Traditional | PDF ↗ |
| K970078 | HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 1997-12-11 | Traditional | PDF ↗ |
| K971492 | AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR | Bei Medical Systems Co., Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K964136 | HYSTERO CO2-PNEU 2221 | Richard Wolf Medical Instruments Corp. | 1997-01-10 | Traditional | PDF ↗ |
| K961091 | KARL STORZ MODEL 203020 20 EQUIMAT | KARL STORZ Endoscopy-America, Inc. | 1996-10-03 | Traditional | PDF ↗ |
| K934866 | HYS-SURGIMAT | W.O.M. World of Medicine GmbH | 1995-10-20 | Traditional | PDF ↗ |
| K933847 | HYS-SURGIFLATOR VP | W.O.M. World of Medicine GmbH | 1995-08-15 | Traditional | PDF ↗ |
| K950961 | KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP | KARL STORZ Endoscopy-America, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K941743 | CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP | Cabot Medical Corp. | 1995-04-19 | Traditional | PDF ↗ |
| K924523 | HYS-SURGIFLATOR | W.O.M. World of Medicine GmbH | 1995-04-11 | Traditional | PDF ↗ |
| K936231 | THE KARL STORZ HAMOU ENDOMAT | Karl Storz Endoscopy | 1995-01-24 | Traditional | PDF ↗ |
| K933384 | BARD HYSTERO-FLO II PUMP | Davol Inc., Sub. C. R. Bard, Inc. | 1994-12-30 | Traditional | PDF ↗ |
| K933873 | CONCEPT UNIVERSAL PUMP SYSTEM | Linvatec Corp. | 1994-12-29 | Traditional | PDF ↗ |
| K921871 | HYSTEROMAT(TM) 3700 | F.M. Wiest USA, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K930912 | HYSTEROMED 100 | Northgate Technologies, Inc. | 1994-10-17 | Traditional | PDF ↗ |
| K922632 | WOM HYSTEROFLATOR OP | W.O.M. GmbH | 1994-03-25 | Traditional | PDF ↗ |
| K931606 | 7-510-25 HYSTEROMED TUBING KIT | Nortech | 1994-01-24 | Traditional | PDF ↗ |
| K922197 | INSUFFLATOR TUBING KIT | O.R. Concepts, Inc. | 1993-09-24 | Traditional | PDF ↗ |
| K912498 | THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR | KARL STORZ Endoscopy-America, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K911844 | HYSTEROFLATOR 1500 | F.M. Wiest USA, Inc. | 1991-11-21 | Traditional | PDF ↗ |
| K912789 | LM-100/200LOW FLOW INSUFFLATOR | Leisegang Medical, Inc. | 1991-09-20 | Traditional | PDF ↗ |
| K905495 | HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR | Frigitronics, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K905706 | GYN-1500 HYSTEROSCOPIC INUFFLATOR | Circon Acmi | 1991-02-28 | Traditional | PDF ↗ |
| K901288 | DAVOL SCOPE IRRIGATION SYSTEM | C.R. Bard, Inc. | 1990-10-10 | Traditional | PDF ↗ |
| K900908 | CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 | Zimmer, Inc. | 1990-05-21 | Traditional | PDF ↗ |
| K894259 | REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA | Washington Regulatory Services | 1990-03-05 | Traditional | PDF ↗ |
| K895659 | HUI MINI-FLEX | Unimar, Inc. | 1989-12-19 | Traditional | PDF ↗ |
| K895907 | HYSTEROFLATOR 2001 | Cabot Medical Corp. | 1989-12-14 | Traditional | PDF ↗ |
| K892001 | DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE | Dexide, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K891028 | UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K881680 | ACKRAD H/S PROCEDURE TRAY | Ackrad Laboratories | 1988-07-15 | Traditional | PDF ↗ |
| K873527 | DECHERNEY HYSTEROSCOPY PUMP SYSTEM | Cabot Medical Corp. | 1988-02-26 | Traditional | PDF ↗ |
| K872860 | INSUFFLATOR TUBING | Medline Industries, Inc. | 1987-11-16 | Traditional | PDF ↗ |
| K842943 | AXCAN UTERINE SUCCION INJECTOR | Axcan Scientific Corp. | 1984-09-21 | Traditional | PDF ↗ |
Product code HIG · Class II · Obstetrics/Gynecology. Data: openFDA.