510(k) K080282 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;
| Applicant | Arthrocare Corp., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 15, 2008 |
| Received | Feb 4, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080282
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2016 | ArthroCare Corporation TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.