Uronirs, Model 2000
FDA 510(k) K082701 · Urodynamix Technologies, Ltd.
510(k) numberK082701
Submission
- Device name
- Uronirs, Model 2000
- Applicant
- Urodynamix Technologies, Ltd.
Vancouver Bc, CA - Received
- September 16, 2008
- Decision date
- December 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEN – Device, Cystometric, Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FEN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212830 | CT3000ProFEN · Traditional | Srs Medical | 12/21/2021SE |
| K073552 | Laborie Urodynamic System with Tetra AccessoryFEN · Traditional | Laborie Medical Technologies, Corp. | 03/05/2008SE |
| K001386 | Accuset Sensor, Model 2000FEN · Traditional | Pelvicare, Inc. | 07/17/2000SE |
| K992715 | Neuro Urodynamic Suite, Model 9032E0101FEN · Traditional | Medtronic Functional Diagnostics A/S | 02/28/2000SE |
| K983325 | In-Probe II Urodynamic SystemFEN · Traditional | Influence, Inc. | 11/24/1998SE |
| K970595 | Circon Endotek OM-4 H2O Cystometry PumpFEN · Traditional | Circon Video | 10/24/1997SE |
| K971911 | Lumax Cystometry Administration Tube SetFEN · Traditional | Medamicus, Inc. | 06/03/1997SE |
| K964522 | Ellipse 4FEN · Traditional | Andromeda Medizinische Systeme GmbH | 03/21/1997SE |
| K960503 | Dantec DuetFEN · Traditional | Dantec Medical, Inc. | 09/16/1996SE |
| K953734 | Lumax(Modification)FEN · Traditional | Medamicus, Inc. | 01/18/1996SE |
Questions and answers
When was Uronirs, Model 2000 cleared by the FDA?
Uronirs, Model 2000 (K082701) received a 510(k) decision of Substantially Equivalent on December 18, 2008, 93 days after the submission was received.
What is the product code of K082701?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.