510(k) K971842 ยท FCG Biopsy Needle
COAXIAL NEEDLE
| Applicant | United States Endoscopy Group, Inc., Mentor OH, US |
| Decision | Substantially Equivalent, Jun 20, 1997 |
| Received | May 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 19, 2016 | US Endoscopy Group Inc Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060
A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flex Terminated |
FBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.