510(k) K171701 ยท FER Anoscope And Accessories
GelPOINT Path Transanal Access Platform
| Applicant | Applied Medical Resources Corp., Rancho Santa CA, US |
| Decision | Substantially Equivalent, Jul 20, 2017 |
| Received | Jun 8, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171701
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2018 | Applied Medical Resources Corp GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm
REF TA211
Product Usage: The GelPOINT Path Transanal Access Platform is indicat Terminated |
FER | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.