GYN-Pump PH304
FDA 510(k) K173489 · W.O.M. World of Medicine GmbH
510(k) numberK173489
Submission
- Device name
- GYN-Pump PH304
- Applicant
- W.O.M. World of Medicine GmbH
Berlin, DE - Received
- November 13, 2017
- Decision date
- March 28, 2018
- 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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| 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 |
| 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 |
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| 510(k) | Device | Decision |
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| K250795 | Purevue FMSHRX · Traditional | 12/05/2025SE |
| K201361 | PneumoclearHIF · Traditional | 07/29/2020SE |
| K173311 | ARTHRO-Pump PA304HRX · Traditional | 05/09/2018SE |
| K172040 | Aquilex Fluid Control System AQL-100SHIG · Special | 02/05/2018SE |
| K170784 | PneumoclearHIF · Traditional | 05/15/2017SE |
| K163320 | LAP-Pump PP110HET · Traditional | 03/21/2017SE |
| K153513 | Insufflator 50L FM134HIF · Traditional | 03/04/2016SE |
| K152109 | HD-Camera HDC1000FET · Traditional | 10/13/2015SE |
| K123732 | Hysteroscopy Pump HM6HIG · Special | 04/04/2013SE |
| K112642 | Aquilex Fluid Control System H112HIG · Traditional | 02/06/2012SE |
Questions and answers
When was GYN-Pump PH304 cleared by the FDA?
GYN-Pump PH304 (K173489) received a 510(k) decision of Substantially Equivalent on March 28, 2018, 135 days after the submission was received.
What is the product code of K173489?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.