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FDA 510(k)

TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly

K-Number: K252020 · 2025-10-15

ApplicantHand Biomechanics Lab, Inc.
Decision Date2025-10-15
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly is the device name listed in this FDA 510(k) record. The listed applicant is Hand Biomechanics Lab, Inc.. It received FDA 510(k) clearance on 2025-10-15 under 510(k) number K252020. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly?

TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly is a medical device that received FDA 510(k) clearance on 2025-10-15. The listed applicant is Hand Biomechanics Lab, Inc.. The 510(k) number is K252020.

When did TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly receive FDA 510(k) clearance?

TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly received FDA 510(k) clearance on 2025-10-15, under 510(k) number K252020.

Who is the listed applicant for TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly?

The FDA 510(k) record lists Hand Biomechanics Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly?

The FDA product code for TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly is HRX.

Related Clinical Trials

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Other records listing Hand Biomechanics Lab, Inc. as applicant

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Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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