510(k) K061050 ยท HET Laparoscope, Gynecologic (And Accessories)
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jul 14, 2006 |
| Received | Apr 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061050
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2009 | Ethicon, Inc. Gynecare Morcellex Tissue Morcellator;
Manufactured by: Ethicon Women's Health & Urology;
A Division of ETHICON INC, a Johnson & Johnson Company, Somerville, NJ 08876 Terminated |
HET | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.