K042877 is an FDA 510(k) clearance for the MICROVERTER URETERAL ACCESS SHEATH. This device is classified as a Accessories, Catheter, G-u (Class II - Special Controls, product code KNY).
Submitted by Percutaneous Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on November 16, 2004, 29 days after receiving the submission on October 18, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K042877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2004 |
| Decision Date | November 16, 2004 |
| Days to Decision | 29 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 |