510(k) K052759 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
DAN MONOPOLAR LAP ACCESSORIES
| Applicant | Dannoritzer Medizintechnik GmbH & Co. KG, Amsterdam, NL |
| Decision | Substantially Equivalent, Jun 14, 2006 |
| Received | Sep 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2018 | Dannoritzer Medizintechnik GmbH & Co. KG Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.