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.. Device class: 2.
Clearance details
- Applicant
- Hand Biomechanics Lab, Inc.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
Recent devices under product code HRX
view allMore clearances from Hand Biomechanics Lab, Inc.
view all- K222490 — HBL Blade Assembly
- K181192 — PIP Fix
- K072432 — F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
- K033112 — WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS
- K030519 — WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
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.