510(k) K142350 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PK J-HOOK
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Jan 8, 2015 |
| Received | Aug 22, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142350
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2020 | Mako Surgical Corporation Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the dist Completed |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.