510(k) K252020
K252020 is an FDA 510(k) premarket notification submitted by Hand Biomechanics Lab, Inc. for the device "TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly". The FDA issued a decision of Substantially Equivalent on October 15, 2025. The device falls under product code HRX (Arthroscope), a Class II device regulated under 21 CFR 888.1100. Hand Biomechanics Lab, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2025
- Date Received
- June 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Arthroscope
- Device Class
- Class II
- Regulation Number
- 888.1100
- Review Panel
- OR
- Submission Type
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).