Uropump Tube & Damping Chamger
FDA 510(k) K953451 · Life-Tech Intl., Inc.
510(k) numberK953451
Submission
- Device name
- Uropump Tube & Damping Chamger
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- July 18, 1995
- Decision date
- October 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
More from Dantec Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001129 | Prolong, Models PL50, PL100, PL150CAZ · Traditional | 07/06/2000SE |
| K955031 | MaxistimKOI · Traditional | 12/10/1996SE |
| K954505 | Ez StimKOI · Traditional | 12/10/1996SE |
| K954315 | PVC Abdominal/Rectal Pressure CatheterFEN · Traditional | 11/30/1995SE |
| K954341 | Urodynamics Tubing and Infusion SetsFEN · Traditional | 10/17/1995SE |
| K953353 | Urovision JanusFEN · Traditional | 09/08/1995SE |
| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
| K913601 | MicrophorEGJ · Traditional | 07/15/1994SE |
| K940203 | Triple Lumen Urodynamic Catheter with Radiopaque MarkersFEN · Traditional | 03/30/1994SE |
| K931179 | Urolab SpectrumFAP · Traditional | 11/18/1993SE |
Questions and answers
When was Uropump Tube & Damping Chamger cleared by the FDA?
Uropump Tube & Damping Chamger (K953451) received a 510(k) decision of Substantially Equivalent on October 5, 1995, 79 days after the submission was received.
What is the product code of K953451?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.