510(k) K012667 ยท HRX Arthroscope
REPROCESSED ARTHROSCOPIC SHAPERS
| Applicant | Surgical Instruments Service and Savings, Inc., Phoenix AZ, US |
| Decision | Substantially Equivalent, Jun 3, 2002 |
| Received | Aug 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012667
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270
- AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665
- AcromioBlaster Burr (Sage Green) 4.0mm Ref Terminated |
HRX | None listed |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609
- CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. Terminated |
NBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.