510(k) K183180 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Caiman 5 Maryland
| Applicant | Aesculap, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Mar 12, 2019 |
| Received | Nov 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183180
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2023 | Aesculap Implant Systems LLC Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.