510(k) K111845 ยท GCJ Laparoscope, General & Plastic Surgery
THE ESPINER SAC OR E SAC
| Applicant | Espiner Medical Limited, Glasgow, GB |
| Decision | Substantially Equivalent, Sep 26, 2011 |
| Received | Jun 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2018 | Espiner Medical Ltd Espiner Tissue Retrieval System-Eco-Sac
Trocar 12mm Vol: 1200 ml
EMP160ECO-US-5 (GTIN:5060358120367)
Product Usage:
Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automat Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.