TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly— 510(k) K252020
Substantially EquivalentHand Biomechanics Lab, Inc.
FDA 510(k) clearance K252020 for TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly, Substantially Equivalent on 2025-10-15. Applicant: Hand Biomechanics Lab, Inc..
Clearance details
- Applicant
- Hand Biomechanics Lab, Inc.
- Product code
- Code HRX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.