K100280 is an FDA 510(k) clearance for the GYNCARE MORCELLEX TISSUE MORCELLATOR. This device is classified as a Laparoscope, Gynecologic (and Accessories) (Class II - Special Controls, product code HET).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on March 24, 2010, 51 days after receiving the submission on February 1, 2010.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K100280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2010 |
| Decision Date | March 24, 2010 |
| Days to Decision | 51 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 |