Home › Device types › HIG
Insufflator, Hysteroscopic
FDA product code HIG · Class 2 · Obstetrics/Gynecology
139
Registered devices
541
Adverse events
6
Recalls
57
510(k) clearances
Devices with this code
ENDOMAT — Karl Storz GmbH & Co. KGTube set for suction, single-use — W.O.M. World of Medicine GmbHAveta Coral Disposable Hysteroscope — MEDITRINA, INC.TRUCLEARTM — Smith & Nephew, Inc.Premier — PREMIER DENTAL PRODUCTS COMPANYn.a. — Karl Storz GmbH & Co. KGNA — Covidien LPGYN-Pump — W.O.M. World of Medicine GmbHAveta Flex+ Disposable Resecting Device, 2.9 mm — MEDITRINA, INC.Tube set for irrigation, single-use — W.O.M. World of Medicine GmbHTube set for irrigation, single use — W.O.M. World of Medicine GmbHHysteroLux™ Fluid Management System Scale — W.O.M. World of Medicine GmbHEQUIMAT — Karl Storz GmbH & Co. KGHysteroscopic Outflow Tube Set — Smith & Nephew, Inc.Aveta Coral Disposable Hysteroscope — MEDITRINA, INC.Aveta Smol Disposable Resecting Device, 2.9 mm — MEDITRINA, INC.Hysteroscopic Fluid Management — Smith & Nephew, Inc.NA — STRYKER CORPORATIONFluid Safe — STRYKER CORPORATIONHysteroscopic Inflow Tube Set — Smith & Nephew, Inc.Symphion Controller - Refurbished — Minerva Surgical, Inc.Aveta Tissue Catch — MEDITRINA, INC.Aveta Waste Management Accessory — MEDITRINA, INC.Fluid Safe — STRYKER CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-09 | Stryker Corporation | Due to nonconforming products being inadvertently distributed. |
| 2023-07-17 | WOM World Of Medicine AG | The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the def |
| 2021-06-18 | WOM World of Medicine AG | When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software cal |
| 2019-08-14 | WOM World of Medicine AG | The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. |
| 2014-09-01 | Thermedx LLC | To correct software bugs that could affect the ability to accurately measure fluid deficit. |
| 2007-08-17 | Karl Storz Endoscopy America Inc | Outflow Difference: The accuracy of the Equimat displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or ina |
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