510(k) K141484 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
OPEN FMSEALER
| Applicant | Domain Surgical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 30, 2014 |
| Received | Jun 5, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141484
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2016 | Domain Surgical, Inc. FMsealer Open Shears. Model FM3001 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.