K142029 is an FDA 510(k) clearance for the MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM. This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by Hologic, Inc. (Malborough, US). The FDA issued a Cleared decision on November 26, 2014, 124 days after receiving the submission on July 25, 2014.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K142029 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2014 |
| Decision Date | November 26, 2014 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |