Panels › Obstetrics/Gynecology › Product code HIG · Class 2
Insufflator, Hysteroscopic
Regulation 884.1700
2510(k)s in 12 months (57 all time)
1recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in HIG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 16, 2026 | K261706 | Endomat Select (UP220) KARL STORZ SE & CO. KG, DE | HIG |
| Mar 27, 2026 | K251273 | Asurys Fluid Management System Boston Scientific Corporation | HIG |
| Jul 25, 2024 | K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT- Hologic, Inc. | HIG |
| Nov 4, 2021 | K210628 | X-FLO Fluid Management System Thermedx, LLC | HIG |
| Jul 22, 2020 | K201355 | Endomat Select, IBS Shaver Software, License Karl Storz SE & CO. KG, DE | HIG |
| Oct 31, 2018 | K180735 | Endomat Select Karl Storz SE & CO. KG, DE | HIG |
| Aug 3, 2018 | K180825 | Fluent Fluid Management System Hologic, Inc. | HIG |
| Mar 28, 2018 | K173489 | GYN-Pump PH304 W.O.M. World of Medicine GmbH, DE | HIG |
| Feb 5, 2018 | K172040 | Aquilex Fluid Control System AQL-100S W.O.M. World of Medicine GmbH, DE | HIG |
| Sep 5, 2017 | K172048 | FluidSmart Thermedx, LLC | HIG |
| Jun 20, 2014 | K133799 | THERMEDX FLUID MANAGMENT SYSTEM Thermedx, LLC | HIG |
| Apr 4, 2013 | K123732 | HYSTEROSCOPY PUMP HM6 W.O.M. World of Medicine AG | HIG |
| Feb 6, 2012 | K112642 | AQUILEX FLUID CONTROL SYSTEM H112 W.O.M. World of Medicine AG | HIG |
| Jul 19, 2011 | K110852 | DOLPHIN 3 FLUID MANAGEMENT SYSTEM Gyrus Acmi, Inc. | HIG |
| Jul 23, 2010 | K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 Thermedx, LLC | HIG |
| Aug 13, 2003 | K031616 | IUR FLUID MANAGEMENT SYSTEM W.O.M. World of Medicine AG | HIG |
| Apr 30, 2003 | K031213 | AQUASENS FLUID MONITORING SYSTEM Davol, Inc. | HIG |
| Apr 10, 2003 | K022449 | HYSTEREOSCOPY PUMP HM4 W.O.M. World of Medicine AG | HIG |
| Jan 8, 2002 | K011876 | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 Circon Video | HIG |
| Aug 16, 2001 | K011069 | AQUASENS FLUID MONITORING SYSTEM Davol Inc., Sub. C. R. Bard, Inc. | HIG |
| Nov 30, 2000 | K000806 | KARL STORZ HYSTEROMAT II KARL STORZ Endoscopy-America, Inc. | HIG |
| Sep 13, 1999 | K991799 | DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO Davol Inc., Sub. C. R. Bard, Inc. | HIG |
| Feb 19, 1999 | K982867 | HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 Davol Inc., Sub. C. R. Bard, Inc. | HIG |
| Jan 14, 1999 | K983889 | HYS-SURGIFLATOR 150P W.O.M. World of Medicine GmbH | HIG |
| Dec 11, 1997 | K970078 | HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM Davol Inc., Sub. C. R. Bard, Inc. | HIG |
| Sep 5, 1997 | K971492 | AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR Bei Medical Systems Co., Inc. | HIG |
| Jan 10, 1997 | K964136 | HYSTERO CO2-PNEU 2221 Richard Wolf Medical Instruments Corp. | HIG |
| Oct 3, 1996 | K961091 | KARL STORZ MODEL 203020 20 EQUIMAT KARL STORZ Endoscopy-America, Inc. | HIG |
| Oct 20, 1995 | K934866 | HYS-SURGIMAT W.O.M. World of Medicine GmbH | HIG |
| Aug 15, 1995 | K933847 | HYS-SURGIFLATOR VP W.O.M. World of Medicine GmbH | HIG |
| May 25, 1995 | K950961 | KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP KARL STORZ Endoscopy-America, Inc. | HIG |
| Apr 19, 1995 | K941743 | CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP Cabot Medical Corp. | HIG |
| Apr 11, 1995 | K924523 | HYS-SURGIFLATOR W.O.M. World of Medicine GmbH | HIG |
| Jan 24, 1995 | K936231 | THE KARL STORZ HAMOU ENDOMAT Karl Storz Endoscopy | HIG |
| Dec 30, 1994 | K933384 | BARD HYSTERO-FLO II PUMP Davol Inc., Sub. C. R. Bard, Inc. | HIG |
| Dec 29, 1994 | K933873 | CONCEPT UNIVERSAL PUMP SYSTEM Linvatec Corp. | HIG |
| Dec 15, 1994 | K921871 | HYSTEROMAT(TM) 3700 F.M. Wiest USA, Inc. | HIG |
| Oct 17, 1994 | K930912 | HYSTEROMED 100 Northgate Technologies, Inc. | HIG |
| Mar 25, 1994 | K922632 | WOM HYSTEROFLATOR OP W.O.M. GmbH, DE | HIG |
| Jan 24, 1994 | K931606 | 7-510-25 HYSTEROMED TUBING KIT Nortech | HIG |
| Sep 24, 1993 | K922197 | INSUFFLATOR TUBING KIT O.R. Concepts, Inc. | HIG |
| Dec 18, 1991 | K912498 | THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR KARL STORZ Endoscopy-America, Inc. | HIG |
| Nov 21, 1991 | K911844 | HYSTEROFLATOR 1500 F.M. Wiest USA, Inc. | HIG |
| Sep 20, 1991 | K912789 | LM-100/200LOW FLOW INSUFFLATOR Leisegang Medical, Inc. | HIG |
| Apr 29, 1991 | K905495 | HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR Frigitronics, Inc. | HIG |
| Feb 28, 1991 | K905706 | GYN-1500 HYSTEROSCOPIC INUFFLATOR Circon Acmi | HIG |
| Oct 10, 1990 | K901288 | DAVOL SCOPE IRRIGATION SYSTEM C.R. Bard, Inc. | HIG |
| May 21, 1990 | K900908 | CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 Zimmer, Inc. | HIG |
| Mar 5, 1990 | K894259 | REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA Washington Regulatory Services | HIG |
| Dec 19, 1989 | K895659 | HUI MINI-FLEX Unimar, Inc. | HIG |
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