K091495 is an FDA 510(k) clearance for the SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A. This device is classified as a Dislodger, Stone, Biliary (Class II - Special Controls, product code LQR).
Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on September 3, 2009, 106 days after receiving the submission on May 20, 2009.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K091495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2009 |
| Decision Date | September 03, 2009 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LQR — Dislodger, Stone, Biliary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |