510(k) K012314 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
DYONICS ELECTROBLADE RESECTOR
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Feb 1, 2002 |
| Received | Jul 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012314
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER
Part Number: 72202213
Product Usage:
The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical Terminated |
GEI | None listed |
| Aug 3, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade
Full Radius
Part Number: 7205962
Product Usage:
The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of l Terminated |
GEI | None listed |
| Jan 11, 2012 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector
Catalog Number: 7205962. Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.