510(k) K223406 ยท HRX Arthroscope
SmartRelease Endoscopic Soft Tissue Release System
| Applicant | Microaire Surgical Instruments, Charlottesville VA, US |
| Decision | Substantially Equivalent, Feb 2, 2023 |
| Received | Nov 9, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223406
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2025 | MicroAire Surgical Instruments, LLC Brand Name: SmartRelease ESTR (Endoscopic soft tissue release
system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic
Carpal Tunnel Release) System, Onyx Blade Assembly;
Common Name: SmartR Open, Classified |
EMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.