Insufflator, Hysteroscopic
FDA product code HIG · Class II (moderate risk) · 21 CFR 884.1700 · Obstetrics/Gynecology
57510(k) clearances
0PMA approvals
6recalls
Manufacturers
- W.O.M. World of Medicine GmbH 10
- Davol, Inc., Sub. C. R. Bard, Inc. 5
- Thermedx, LLC 4
- KARL STORZ Endoscopy-America, Inc. 4
- Cabot Medical Corp. 3
- Karl Storz SE & CO. KG 3
- Hologic, Inc. 2
- F.M. Wiest USA, Inc. 2
- Circon Acmi 1
- W.O.M. GmbH 1
- O.R. Concepts, Inc. 1
- Leisegang Medical, Inc. 1
- Frigitronics, Inc. 1
- Boston Scientific Corporation 1
- Zimmer, Inc. 1
- Washington Regulatory Services 1
- Unimar, Inc. 1
- Dexide, Inc. 1
- Zinnanti Surgical Instruments, Inc. 1
- Ackrad Laboratories 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261706 | Endomat Select (UP220)HIG · Traditional | Karl Storz Se & Co. KG | 07/16/2026SE |
| K251273 | Asurys Fluid Management SystemHIG · Traditional | Boston Scientific Corporation | 03/27/2026SE |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional | Hologic, Inc. | 07/25/2024SE |
| K210628 | X-FLO Fluid Management SystemHIG · Traditional | Thermedx, LLC | 11/04/2021SE |
| K201355 | Endomat Select, IBS Shaver Software, LicenseHIG · Special | Karl Storz SE & CO. KG | 07/22/2020SE |
| K180735 | Endomat SelectHIG · Traditional | Karl Storz SE & CO. KG | 10/31/2018SE |
| K180825 | Fluent Fluid Management SystemHIG · Traditional | Hologic, Inc. | 08/03/2018SE |
| K173489 | GYN-Pump PH304HIG · Traditional | W.O.M. World of Medicine GmbH | 03/28/2018SE |
| K172040 | Aquilex Fluid Control System AQL-100SHIG · Special | W.O.M. World of Medicine GmbH | 02/05/2018SE |
| K172048 | FluidSmartHIG · Special | Thermedx, LLC | 09/05/2017SE |
| K133799 | Thermedx Fluid Managment SystemHIG · Traditional | Thermedx, LLC | 06/20/2014SE |
| K123732 | Hysteroscopy Pump HM6HIG · Special | W.O.M. World of Medicine AG | 04/04/2013SE |
| K112642 | Aquilex Fluid Control System H112HIG · Traditional | W.O.M. World of Medicine AG | 02/06/2012SE |
| K110852 | Dolphin 3 Fluid Management SystemHIG · Traditional | Gyrus Acmi, Inc. | 07/19/2011SE |
| K091939 | Thermedx Prodigy Fluid Management System, Models P1000, P2000HIG · Traditional | Thermedx, LLC | 07/23/2010SE |
| K031616 | Iur Fluid Management SystemHIG · Special | W.O.M. World of Medicine AG | 08/13/2003SE |
| K031213 | Aquasens Fluid Monitoring SystemHIG · Traditional | Davol, Inc. | 04/30/2003SE |
| K022449 | Hystereoscopy Pump HM4HIG · Traditional | W.O.M. World of Medicine AG | 04/10/2003SE |
| K011876 | Dolphin II Fluid Management System, Model DOL-2HIG · Traditional | Circon Video | 01/08/2002SE |
| K011069 | Aquasens Fluid Monitoring SystemHIG · Traditional | Davol Inc., Sub. C. R. Bard, Inc. | 08/16/2001SE |
| K000806 | Karl Storz Hysteromat IIHIG · Traditional | KARL STORZ Endoscopy-America, Inc. | 11/30/2000SE |
| K991799 | Davol Hysteroscopy Pouch Drape and Tubing Set, Model OoxxxxoHIG · Traditional | Davol Inc., Sub. C. R. Bard, Inc. | 09/13/1999SE |
| K982867 | Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000HIG · Traditional | Davol Inc., Sub. C. R. Bard, Inc. | 02/19/1999SE |
| K983889 | Hys-Surgiflator 150PHIG · Traditional | W.O.M. World of Medicine GmbH | 01/14/1999SE |
| K970078 | Hydrofloex HD Hysteroscopic Distention SystemHIG · Traditional | Davol Inc., Sub. C. R. Bard, Inc. | 12/11/1997SE |
| K971492 | Automatic Electronic Hysteroscopic InsufflatorHIG · Traditional | Bei Medical Systems Co., Inc. | 09/05/1997SE |
| K964136 | Hystero CO2-PNEU 2221HIG · Traditional | Richard Wolf Medical Instruments Corp. | 01/10/1997SE |
| K961091 | Karl Storz Model 203020 20 EquimatHIG · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/03/1996SE |
| K934866 | Hys-SurgimatHIG · Traditional | W.O.M. World of Medicine GmbH | 10/20/1995SE |
| K933847 | Hys-Surgiflator VPHIG · Traditional | W.O.M. World of Medicine GmbH | 08/15/1995SE |
| K950961 | Ksea Disposable Tubing Sets for the Hamou Endomat PumpHIG · Traditional | KARL STORZ Endoscopy-America, Inc. | 05/25/1995SE |
| K941743 | Cabot Medical Niagara Fluid Management PumpHIG · Traditional | Cabot Medical Corp. | 04/19/1995SE |
| K924523 | Hys-SurgiflatorHIG · Traditional | W.O.M. World of Medicine GmbH | 04/11/1995SE |
| K936231 | The Karl Storz Hamou EndomatHIG · Traditional | Karl Storz Endoscopy | 01/24/1995SE |
| K933384 | Bard Hystero-Flo II PumpHIG · Traditional | Davol Inc., Sub. C. R. Bard, Inc. | 12/30/1994SE |
| K933873 | Concept Universal Pump SystemHIG · Traditional | Linvatec Corp. | 12/29/1994SE |
| K921871 | Hysteromat(Tm) 3700HIG · Traditional | F.M. Wiest USA, Inc. | 12/15/1994SE |
| K930912 | Hysteromed 100HIG · Traditional | Northgate Technologies, Inc. | 10/17/1994SE |
| K922632 | Wom Hysteroflator OpHIG · Traditional | W.O.M. GmbH | 03/25/1994SE |
| K931606 | 7-510-25 Hysteromed Tubing KitHIG · Traditional | Nortech | 01/24/1994SE |
| K922197 | Insufflator Tubing KitHIG · Traditional | O.R. Concepts, Inc. | 09/24/1993SE |
| K912498 | The Karl Storz 26025UC Hamou Elec HysteroflatorHIG · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/18/1991SE |
| K911844 | Hysteroflator 1500HIG · Traditional | F.M. Wiest USA, Inc. | 11/21/1991SE |
| K912789 | LM-100/200LOW Flow InsufflatorHIG · Traditional | Leisegang Medical, Inc. | 09/20/1991SE |
| K905495 | Hysteromat Hysteroflator Hysteroscopic InsufflatorHIG · Traditional | Frigitronics, Inc. | 04/29/1991SE |
| K905706 | GYN-1500 Hysteroscopic InufflatorHIG · Traditional | Circon Acmi | 02/28/1991SE |
| K901288 | Davol Scope Irrigation SystemHIG · Traditional | C.R. Bard, Inc. | 10/10/1990SE |
| K900908 | Controlled Distention Irrigation System Cdis 200HIG · Traditional | Zimmer, Inc. | 05/21/1990SE |
| K894259 | Register, a Disposable Hysterography CupulaHIG · Traditional | Washington Regulatory Services | 03/05/1990SE |
| K895659 | Hui Mini-FlexHIG · Traditional | Unimar, Inc. | 12/19/1989SE |
| K895907 | Hysteroflator 2001HIG · Traditional | Cabot Medical Corp. | 12/14/1989SE |
| K892001 | Dex-Cell Hysteroscopy Fluid Delivery DeviceHIG · Traditional | Dexide, Inc. | 06/16/1989SE |
| K891028 | Uterine Cannula - Kahn, Jarco, Corson, RatchetHIG · Traditional | Zinnanti Surgical Instruments, Inc. | 03/17/1989SE |
| K881680 | Ackrad H/S Procedure TrayHIG · Traditional | Ackrad Laboratories | 07/15/1988SESD |
| K873527 | Decherney Hysteroscopy Pump SystemHIG · Traditional | Cabot Medical Corp. | 02/26/1988SE |
| K872860 | Insufflator TubingHIG · Traditional | Medline Industries, Inc. | 11/16/1987SE |
| K842943 | Axcan Uterine Succion InjectorHIG · Traditional | Axcan Scientific Corp. | 09/21/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2166-2026 Class II | Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The…Due to nonconforming products being inadvertently distributed. | Stryker Corporation | 04/09/2026Open, Classified |
| Z-2629-2023 Class II | Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during…The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume… | WOM World Of Medicine AG | 07/17/2023Open, Classified |
| Z-2561-2021 Class II | Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit… | WOM World of Medicine AG | 06/18/2021Open, Classified |
| Z-2767-2019 Class II | Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage:…The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. | WOM World of Medicine AG | 08/14/2019Terminated |
| Z-1463-2015 Class II | Fluid Management System P4000; for irrigation and fluid warming in laparoscopic…To correct software bugs that could affect the ability to accurately measure fluid deficit. | Thermedx LLC | 09/01/2014Terminated |
| Z-0144-2008 | Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number…Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of… | Karl Storz Endoscopy America Inc | 08/17/2007Terminated |