Uropump Model 1711
FDA 510(k) K843224 · Life-Tech Intl., Inc.
510(k) numberK843224
Submission
- Device name
- Uropump Model 1711
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- August 16, 1984
- Decision date
- October 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1800
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893827 | Peak Flow Rate MeterFFG · Traditional | Laytech Medical Co. | 08/11/1989SE |
| K883274 | Surgitek (R) Uroflow SystemFFG · Traditional | Medical Engineering Corp. | 02/08/1989SE |
| K850169 | Eris Uro-Diagnostic SystemFFG · Traditional | Eris Medical Technology | 04/22/1985SE |
| K844338 | 1URO-LOG Home Diagnostic PackFFG · Traditional | Epcom Medical Systems, Inc. | 02/25/1985SE |
| K843442 | Urinary Drainage Container 2013 withFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K843441 | Urinary Drainage Container 2012-WITHFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K844030 | Accumeter Electronic Urinemeter SystemFFG · Traditional | Travenol Laboratories, S.A. | 11/20/1984SE |
| K833043 | UrometerFFG · Traditional | Browne Medical, Inc. | 02/04/1984SE |
| K813641 | Vital Metrics Urine Monitoring SystemFFG · Traditional | Vital Metrics, Inc. | 03/01/1982SE |
| K813082 | Ureofix 500 Urine Measuring SystemFFG · Traditional | Burron Medical Products, Inc. | 12/31/1981SE |
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| 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 |
| K953451 | Uropump Tube & Damping ChamgerFEN · Traditional | 10/05/1995SE |
| 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 |
Questions and answers
When was Uropump Model 1711 cleared by the FDA?
Uropump Model 1711 (K843224) received a 510(k) decision of Substantially Equivalent on October 19, 1984, 64 days after the submission was received.
What is the product code of K843224?
The FDA product code is FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.1800.