Modified Uropump* Fluid Management System
FDA 510(k) K895643 · Orthoconcept, Inc.
510(k) numberK895643
Submission
- Device name
- Modified Uropump* Fluid Management System
- Applicant
- Orthoconcept, Inc.
Columbia, SC, US - Received
- August 28, 1989
- Decision date
- October 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FDC – Resectoscope, Working Element
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021166 | Acmi Bipolar Rectoscope, Model Eiwe-BrFDC · Special | Acmi-Circon Corporation | 05/09/2002SE |
| K992141 | Olympus Working Element for ProbesFDC · Traditional | Olympus Winter & Ibe GmbH | 09/29/1999SE |
| K991426 | Mahe InstrumentsFDC · Traditional | Mahe Intl., Inc. | 08/05/1999SE |
| K942626 | Continuous Flow Biopsy ProbeFDC · Traditional | Gm Engineering, Inc. | 05/30/1995SE |
| K933962 | GM Continuous Flow Biopsy ProbeFDC · Traditional | Gm Engineering, Inc. | 02/25/1994SE |
| K894363 | Uropump* Fluid Management SystemFDC · Traditional | Orthoconcept, Inc. | 08/11/1989SE |
| K842997 | Laser Rectoscope Set 784FDC · Traditional | Laser Industries , Ltd. | 08/27/1984SE |
| K760184 | Element, WorkingFDC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/02/1976SE |
| K760182 | Sheath, ResectoscopeFDC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/02/1976SE |
| K760174 | Adapter, ResectoscopeFDC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 08/30/1976SE |
More from V. Mueller O.V. Baxter Healthcare Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K925160 | Arthro FMS 4HRX · Traditional | 02/17/1994SE |
| K910164 | Orthoconcept Arthroscopic PumpHRX · Traditional | 03/27/1991SE |
| K905785 | ARTHRO-FMS-3/IRRIGATION Sets (Various)HRX · Traditional | 03/26/1991SE |
| K896196 | Arthroscopy Disp. & Reusable Shaver Blades, RecharHRX · Traditional | 12/01/1989SE |
| K894363 | Uropump* Fluid Management SystemFDC · Traditional | 08/11/1989SE |
| K882469 | Cordex Shaver, Blades, Recharger and BatteriesHRX · Traditional | 12/01/1988SE |
| K872270 | Orthoconcept Arthroscopic Pump OrthopumpHRX · Traditional | 07/21/1987SE |
Questions and answers
When was Modified Uropump* Fluid Management System cleared by the FDA?
Modified Uropump* Fluid Management System (K895643) received a 510(k) decision of Substantially Equivalent on October 17, 1989, 50 days after the submission was received.
What is the product code of K895643?
The FDA product code is FDC – Resectoscope, Working Element, a Class II (moderate risk) device regulated under 21 CFR 876.1500.