Wom Hysteroflator Op

FDA 510(k) K922632 · W.O.M. GmbH

Substantially Equivalent

510(k) numberK922632

Submission

Device name
Wom Hysteroflator Op
Applicant
W.O.M. GmbH
Berlin, DE
Received
March 4, 1992
Decision date
March 25, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HIG – Insufflator, Hysteroscopic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1700
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HIG

510(k)DeviceApplicantDecision
K261706Endomat Select (UP220)HIG · Traditional Karl Storz Se & Co. KG07/16/2026SE
K251273Asurys Fluid Management SystemHIG · Traditional Boston Scientific Corporation03/27/2026SE
K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional Hologic, Inc.07/25/2024SE
K210628X-FLO Fluid Management SystemHIG · Traditional Thermedx, LLC11/04/2021SE
K201355Endomat Select, IBS Shaver Software, LicenseHIG · Special Karl Storz SE & CO. KG07/22/2020SE
K180735Endomat SelectHIG · Traditional Karl Storz SE & CO. KG10/31/2018SE
K180825Fluent Fluid Management SystemHIG · Traditional Hologic, Inc.08/03/2018SE
K173489GYN-Pump PH304HIG · Traditional W.O.M. World of Medicine GmbH03/28/2018SE
K172040Aquilex Fluid Control System AQL-100SHIG · Special W.O.M. World of Medicine GmbH02/05/2018SE
K172048FluidSmartHIG · Special Thermedx, LLC09/05/2017SE

More from Thermedx, LLC

510(k)DeviceDecision
K950035Surgiflator 20HIF · Traditional 02/12/1996SE
K921086Wom Laparoflator ElectronicGCJ · Traditional 04/07/1992SE

Questions and answers

When was Wom Hysteroflator Op cleared by the FDA?

Wom Hysteroflator Op (K922632) received a 510(k) decision of Substantially Equivalent on March 25, 1994, 751 days after the submission was received.

What is the product code of K922632?

The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.