K051593 is an FDA 510(k) clearance for the UROPASS URETERAL ACCESS SHEATH, MODEL 61224, a Accessories, Catheter, G-u (Class II — Special Controls, product code KNY), submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on September 2, 2005, 78 days after receiving the submission on June 16, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K051593 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 16, 2005 |
| Decision Date | September 02, 2005 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNY — Accessories, Catheter, G-u |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |