510(k) K072216 ยท NEU Marker, Radiographic, Implantable
KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
| Applicant | Kapp Surgical Instrument, Inc., Warrensville OH, US |
| Decision | Substantially Equivalent, Nov 9, 2007 |
| Received | Aug 9, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2011 | Kapp Surgical Instrument Inc Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box wi Terminated |
NEU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.