K151011 is an FDA 510(k) clearance for the VISERA 4K UHD SYSTEM. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by Olympus Medical Systems Corp. (Hachioji-Shi, JP). The FDA issued a Cleared decision on October 1, 2015, 169 days after receiving the submission on April 15, 2015.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K151011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2015 |
| Decision Date | October 01, 2015 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HET — Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1720 |