510(k) K042796 ยท HWC Screw, Fixation, Bone
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
| Applicant | Coapt Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Nov 5, 2004 |
| Received | Oct 7, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2016 | MicroAire Surgical Instruments, LLC Endotine Transbleph 3.5 (CFD-080-0167) Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.