Hystereoscopy Pump HM4
FDA 510(k) K022449 · W.O.M. World of Medicine AG
510(k) numberK022449
Submission
- Device name
- Hystereoscopy Pump HM4
- Applicant
- W.O.M. World of Medicine AG
Cambridge, MA, US - Received
- July 26, 2002
- Decision date
- April 10, 2003
- 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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| 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 |
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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 |
| K173489 | GYN-Pump PH304HIG · Traditional | 03/28/2018SE |
| 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 |
Questions and answers
When was Hystereoscopy Pump HM4 cleared by the FDA?
Hystereoscopy Pump HM4 (K022449) received a 510(k) decision of Substantially Equivalent on April 10, 2003, 258 days after the submission was received.
What is the product code of K022449?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.