510(k) K003871 ยท GCJ Laparoscope, General & Plastic Surgery
LAPAROSCOPIC HAND PORT
| Applicant | Applied Medical Resources Corp., Rancho Santa CA, US |
| Decision | Substantially Equivalent, May 31, 2001 |
| Received | Dec 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003871
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2005 | Applied Medical Resources Corp The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubric Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.