The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Morcellex Sigma Generator.
| Device ID | K131656 |
| 510k Number | K131656 |
| Device Name: | MORCELLEX SIGMA GENERATOR |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Contact | Sarah Mcmanus |
| Correspondent | Sarah Mcmanus ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-06 |
| Decision Date | 2013-09-27 |
| Summary: | summary |