Thermedx Prodigy Fluid Management System, Models P1000, P2000
FDA 510(k) K091939 · Thermedx, LLC
510(k) numberK091939
Submission
- Device name
- Thermedx Prodigy Fluid Management System, Models P1000, P2000
- Applicant
- Thermedx, LLC
Solon, OH, US - Received
- June 30, 2009
- Decision date
- July 23, 2010
- 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 |
|---|---|---|
| K210628 | X-FLO Fluid Management SystemHIG · Traditional | 11/04/2021SE |
| K172048 | FluidSmartHIG · Special | 09/05/2017SE |
| K133799 | Thermedx Fluid Managment SystemHIG · Traditional | 06/20/2014SE |
| K102275 | Thermedx 37-5 Electrocautery Probes, Models MPJ200, MPJ210, MPS220, MPN230, BPH240GEI · Traditional | 03/25/2011SE |
Questions and answers
When was Thermedx Prodigy Fluid Management System, Models P1000, P2000 cleared by the FDA?
Thermedx Prodigy Fluid Management System, Models P1000, P2000 (K091939) received a 510(k) decision of Substantially Equivalent on July 23, 2010, 388 days after the submission was received.
What is the product code of K091939?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.