510(k) K973297 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
COSMAN COAGULATOR (CC-1) SYSTEM
| Applicant | Radionics, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Oct 29, 1997 |
| Received | Sep 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2012 | Nellcor Puritan Bennett Inc. (dba Covidien LP) DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads)
The product is used during ablation surgical procedures. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.