510(k) K171684 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Epix Electrosurgical Probe with Smoke Evacuation
| Applicant | Applied Medical Resources Corporation, Rancho Santa CA, US |
| Decision | Substantially Equivalent, Aug 7, 2017 |
| Received | Jun 7, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2018 | Applied Medical Resources Corp Epix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm
REF CW002 QTY: 1 - Product Usage:
The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.