Hysteromat(Tm) 3700
FDA 510(k) K921871 · F.M. Wiest USA, Inc.
510(k) numberK921871
Submission
- Device name
- Hysteromat(Tm) 3700
- Applicant
- F.M. Wiest USA, Inc.
Oradell, NJ, US - Received
- April 20, 1992
- Decision date
- December 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIG – Insufflator, Hysteroscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1700
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
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| 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 |
More from Thermedx, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K920574 | Camsys 6300EXQ · Traditional | 02/17/1993SE |
| K920575 | Merkur 4000FAP · Traditional | 07/23/1992SE |
| K915751 | Ureteromat 4400EZN · Traditional | 04/24/1992SE |
| K911844 | Hysteroflator 1500HIG · Traditional | 11/21/1991SE |
| K912071 | Space(Tm) 7500IKN · Traditional | 07/09/1991SE |
| K910883 | Laparoflator Electronic 3509HIF · Traditional | 03/29/1991SE |
| K875137 | Laparoflator 3000, Standard and ElectronicHES · Traditional | 03/02/1988SE |
| K871181 | Arthrocombi 5003HRX · Traditional | 09/29/1987SE |
| K871180 | Arthro Automat 5002HRX · Traditional | 09/29/1987SE |
| K865066 | ArthroflatorHRX · Traditional | 04/20/1987SE |
Questions and answers
When was Hysteromat(Tm) 3700 cleared by the FDA?
Hysteromat(Tm) 3700 (K921871) received a 510(k) decision of Substantially Equivalent on December 15, 1994, 969 days after the submission was received.
What is the product code of K921871?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.