Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Hand Biomechanics Lab, Inc.. It received FDA 510(k) clearance on 2025-10-15 under approval 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. It is manufactured by Hand Biomechanics Lab, Inc.. The 510(k) number is K252020.

When was TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly approved by the FDA?

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

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

TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly is manufactured by Hand Biomechanics Lab, Inc..

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

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

Other Devices by Hand Biomechanics Lab, Inc.

K181192PIP Fix K222490HBL Blade Assembly

Related Devices (Code: HRX)

K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation K161878PORTAGE SystemBaylis Medical Company, Inc. K162475mi-eye 2, mi-eye 2 monitorTrice Medical K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc. K160249ULTRA TelescopesOlympus Winter & Ibe GmbH K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation

Official Source

View on FDA Database →

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

↑