K905289 is an FDA 510(k) clearance for the SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT. This device is classified as a Stent, Ureteral (Class II - Special Controls, product code FAD).
Submitted by Medical Engineering Corp. (Racine, US). The FDA issued a Cleared decision on March 13, 1991, 107 days after receiving the submission on November 26, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4620.
| 510(k) Number | K905289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1990 |
| Decision Date | March 13, 1991 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FAD — Stent, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4620 |