The Karl Storz Hamou Endomat
FDA 510(k) K936231 · Karl Storz Endoscopy
510(k) numberK936231
Submission
- Device name
- The Karl Storz Hamou Endomat
- Applicant
- Karl Storz Endoscopy
Culver City, CA, US - Received
- December 29, 1993
- Decision date
- January 24, 1995
- 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
Other 510(k)s with product code HIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261706 | Endomat Select (UP220)HIG · Traditional | Karl Storz Se & Co. KG | 07/16/2026SE |
| 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 |
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| K023924 | Autocon II 200 Electrosurgical GeneratorGEI · Traditional | 02/21/2003SE |
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| K011700 | Modulith SLK LithotripterLNS · Traditional | 08/16/2002SE |
| K021776 | Ksea Quadro SwitchOCX · Traditional | 08/15/2002SE |
| K013107 | Bioabsorbable Interference Screw MegafixHWC · Traditional | 02/26/2002SE |
| K011841 | Ksea Sawahle Electromechanical MorcellatorGCJ · Traditional | 09/10/2001SE |
| K010569 | Ksea Universal Laparomat Laparoscopic Suction and Irrigation PumpGCJ · Traditional | 04/09/2001SE |
Questions and answers
When was The Karl Storz Hamou Endomat cleared by the FDA?
The Karl Storz Hamou Endomat (K936231) received a 510(k) decision of Substantially Equivalent on January 24, 1995, 391 days after the submission was received.
What is the product code of K936231?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.