K042531 is an FDA 510(k) clearance for the UPDATED SLIP UROLOGY INTRODUCER SHEATH. This device is classified as a Accessories, Catheter, G-u (Class II - Special Controls, product code KNY).
Submitted by Percutaneous Systems, Incorporated (Mountain View, US). The FDA issued a Cleared decision on February 1, 2005, 137 days after receiving the submission on September 17, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K042531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2004 |
| Decision Date | February 01, 2005 |
| Days to Decision | 137 days |
| Submission Type | Special |
| 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 |