510(k) K063192 ยท LFL Instrument, Ultrasonic Surgical
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP
| Applicant | Ethicon Endo-Surgery, LLC, Cincinnati OH, US |
| Decision | Substantially Equivalent, Jan 30, 2007 |
| Received | Oct 20, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063192
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2012 | Ethicon Endo-Surgery Inc HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.