510(k) K042882 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
ENTERYX INJECTION CATHETER
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Nov 9, 2004 |
| Received | Oct 19, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042882
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2005 | Boston Scientific Corporation Enteryx Procedure Kit
Order No.: M00572600 -US and M00572500 -OUS Terminated |
LNM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.