K022135 is an FDA 510(k) clearance for the URETERAL ACCESS SHEATH SET (UASS). This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on September 13, 2002, 74 days after receiving the submission on July 1, 2002.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K022135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2002 |
| Decision Date | September 13, 2002 |
| Days to Decision | 74 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |