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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2026 | Stryker Corporation Thermedx FluidSmart Urology Tube Set REF LL0006
UDI-DI code: 00860936000365
The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigat Open, Classified |
HIG | K172048 |
| Jan 5, 2024 | WOM World Of Medicine AG Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowi Open, Classified |
HIG | K172040 |
| Jun 18, 2021 | WOM World of Medicine AG Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 Open, Classified |
HIG | K173489 |
| Aug 14, 2019 | WOM World of Medicine AG Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS
Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. Terminated |
HIG | K172040 |
| Apr 20, 2015 | Thermedx LLC Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, Terminated |
HIG | K091939 K133799 |
| Nov 7, 2007 | Karl Storz Endoscopy America Inc Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product Number 26601EQ-KT Terminated |
HIG | None listed |
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