Cleared Traditional

HBL Blade Assembly

K222490 · Hand Biomechanics Lab, Inc. · Orthopedic

Nov 2022

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K222490 is an FDA 510(k) clearance for 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 November 14, 2022, 89 days after receiving the submission on August 17, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K222490 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2022
Decision Date	November 14, 2022
Days to Decision	89 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).