510(k) K912871 ยท HRX Arthroscope
INSIDE JOB
| Applicant | 3M Health Care, Ltd., St. Paul MN, US |
| Decision | Substantially Equivalent, Aug 9, 1991 |
| Received | Jun 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912871
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2019 | MicroAire Surgical Instruments, LLC SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014 Terminated |
HRX | None listed |
| May 25, 2018 | MicroAire Surgical Instruments, LLC MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D
The MicroAire Carpal Tunnel Release System is for use in patients diagnosed w Terminated |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.