Cleared Traditional

TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly

K252020 · Hand Biomechanics Lab, Inc. · Orthopedic

Oct 2025

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K252020 is an FDA 510(k) clearance for the TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on October 15, 2025, 107 days after receiving the submission on June 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K252020 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2025
Decision Date	October 15, 2025
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	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).