510(k) K083895 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
CODMAN ISOCOOL BIPOLAR FORCEPS
| Applicant | Codman & Shurtleff, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Jun 23, 2009 |
| Received | Dec 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083895
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2019 | Integra LifeSciences Corp. Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plas Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.