Hystero CO2-PNEU 2221
FDA 510(k) K964136 · Richard Wolf Medical Instruments Corp.
510(k) numberK964136
Submission
- Device name
- Hystero CO2-PNEU 2221
- Applicant
- Richard Wolf Medical Instruments Corp.
Vernon Hills, IL, US - Received
- October 15, 1996
- Decision date
- January 10, 1997
- 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 |
More from Thermedx, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K231291 | Perforated BasketsKCT · Traditional | 06/03/2024SE |
| K230194 | HF Surgery Generator 400KHZGEI · Traditional | 03/22/2023SE |
| K212808 | Logic Hd camera head green, System greenFET · Traditional | 06/14/2022SE |
| K211332 | D Camera ControllerFET · Traditional | 10/01/2021SE |
| K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL…GCM · Traditional | 05/14/2021SE |
| K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525FGB · Traditional | 01/15/2021SE |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…FET · Traditional | 06/23/2020SE |
| K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA…FGB · Traditional | 05/03/2019SE |
| K180583 | Logic 4K Camera Controller, Logic 4K Camera HeadFET · Traditional | 06/28/2018SE |
| K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL…GEI · Traditional | 04/05/2017SE |
Questions and answers
When was Hystero CO2-PNEU 2221 cleared by the FDA?
Hystero CO2-PNEU 2221 (K964136) received a 510(k) decision of Substantially Equivalent on January 10, 1997, 87 days after the submission was received.
What is the product code of K964136?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.