510(k) K100543 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
| Applicant | Medisiss, Redmond OR, US |
| Decision | Substantially Equivalent, Jul 23, 2010 |
| Received | Feb 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100543
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2025 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.