K123365 is an FDA 510(k) clearance for the OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by Olympus Medical Systems Corp. (Center Valley, US). The FDA issued a Cleared decision on March 1, 2013, 121 days after receiving the submission on October 31, 2012.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K123365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2012 |
| Decision Date | March 01, 2013 |
| Days to Decision | 121 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 |