K123170 is an FDA 510(k) clearance for the VARI-PASS VARIABLE LENGTH ACCESS SHEATH. This device is classified as a Accessories, Catheter, G-u (Class II - Special Controls, product code KNY).
Submitted by Olympus Surgical Technologies America (Southborough, US). The FDA issued a Cleared decision on February 4, 2013, 118 days after receiving the submission on October 9, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K123170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2012 |
| Decision Date | February 04, 2013 |
| Days to Decision | 118 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 |