510(k) K925573 ยท HRX Arthroscope
ACUFEX T-BAR
| Applicant | Acufex Microsurgical, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, May 5, 1993 |
| Received | Nov 3, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925573
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2020 | Smith & Nephew, Inc. Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures.
REF/ Catalog Number : 014771 Open, Classified |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.