510(k) K083638 ยท GCJ Laparoscope, General & Plastic Surgery
FIXATION TROCARS
| Applicant | Applied Medical Resources Corp., Rancho Santa CA, US |
| Decision | Substantially Equivalent, Dec 23, 2008 |
| Received | Dec 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083638
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2019 | Applied Medical Resources Corp Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp.
Product Usage:
Kii Fios first entry is indicated for use in g Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.