K911475 is an FDA 510(k) clearance for the LAPAROSCOPIC VESSEL ARTICULATOR. This device is classified as a Dilator, Vessel, Surgical (Class II - Special Controls, product code DWP).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on July 2, 1991, 89 days after receiving the submission on April 4, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4475.
| 510(k) Number | K911475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1991 |
| Decision Date | July 02, 1991 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DWP - Dilator, Vessel, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4475 |