K926088 is an FDA 510(k) clearance for the FST CATH UD-DUAL DUAL PRESSURE CATHETER. This device is classified as a Device, Cystometric, Hydraulic (Class II - Special Controls, product code FEN).
Submitted by Fiberoptic Sensor Technlogies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on June 18, 1993, 198 days after receiving the submission on December 2, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K926088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1992 |
| Decision Date | June 18, 1993 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FEN — Device, Cystometric, Hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |