FDA 510(k)

HBL Blade Assembly

K-Number: K222490 · 2022-11-14

Decision Date2022-11-14

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HBL Blade Assembly is a medical device manufactured by Hand Biomechanics Lab, Inc.. It received FDA 510(k) clearance on 2022-11-14 under approval number K222490. 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 HBL Blade Assembly?

HBL Blade Assembly is a medical device that received FDA 510(k) clearance on 2022-11-14. It is manufactured by Hand Biomechanics Lab, Inc.. The 510(k) number is K222490.

When was HBL Blade Assembly approved by the FDA?

HBL Blade Assembly received FDA 510(k) clearance on 2022-11-14, under approval number K222490.

What company makes HBL Blade Assembly?

HBL Blade Assembly is manufactured by Hand Biomechanics Lab, Inc..

What is the FDA product code for HBL Blade Assembly?

The FDA product code for HBL Blade Assembly is HRX.

Other Devices by Hand Biomechanics Lab, Inc.

K181192PIP Fix K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL 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

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