510(k) K132612 ยท LFL Instrument, Ultrasonic Surgical
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE
| Applicant | Ethicon Endo-Surgery, LLC, Cincinnati OH, US |
| Decision | Substantially Equivalent, Oct 17, 2013 |
| Received | Aug 21, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132612
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2015 | Ethicon Endo-Surgery Inc HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.