SmartRelease Endoscopic Soft Tissue Release System
FDA 510(k) clearance K223406 · decided 2023-02-02
Clearance details
- K-number
- K223406
- Device name
- SmartRelease Endoscopic Soft Tissue Release System
- Applicant
- Microaire Surgical Instruments
- Decision
- Substantially Equivalent
- Date received
- 2022-11-09
- Decision date
- 2023-02-02
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Charlottesville, VA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Microaire Surgical Instruments
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly recall (Z-1975-2025) | MicroAire Surgical Instruments, LLC | 2025-06-12 |