510(k) K012669 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
REPROCESSED ELECTROSURGICAL ELECTRODES
| Applicant | Surgical Instruments Service and Savings, Inc., Phoenix AZ, US |
| Decision | Substantially Equivalent, Jun 27, 2002 |
| Received | Aug 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012669
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2025 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated
Cable, Item Number REF EICA58720R Open, Classified |
GEI | None listed |
| Apr 9, 2025 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R Open, Classified |
GEI | None listed |
| Apr 9, 2025 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R Open, Classified |
GEI | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502
-Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288
-CAPSure 30 A Terminated |
GEI | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762
Unclassified Terminated |
NLQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.