K052134 is an FDA 510(k) clearance for the CYSTOGLIDE DILATING INTRODUCER 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 September 22, 2005, 48 days after receiving the submission on August 5, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K052134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2005 |
| Decision Date | September 22, 2005 |
| Days to Decision | 48 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 |