Home / 510(k) Clearances / K252020

510(k) K252020

TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly by Hand Biomechanics Lab, Inc. — Product Code HRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2025
Date Received
June 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Arthroscope
Device Class
Class II
Regulation Number
888.1100
Review Panel
OR
Submission Type

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).

Other clearances by Hand Biomechanics Lab, Inc.

  • K222490 — HBL Blade Assembly (November 14, 2022)
  • K181192 — PIP Fix (October 22, 2018)
  • K072432 — F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (January 9, 2008)
  • K033112 — WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-3 (November 5, 2003)
  • K030519 — WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, C (June 10, 2003)
  • K992970 — DIGIT WIDGET (November 8, 1999)
  • K984442 — AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 (February 12, 1999)
  • K942906 — AGEE-WRISTJACK PRE-DRILL KIT (December 22, 1994)

Other clearances for product code HRX

  • K252546 — VantageTM Lumbar Decompression Kit (March 12, 2026)
  • K253217 — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet ( (December 23, 2025)
  • K250795 — PUREVUE™ FMS (December 5, 2025)
  • K252666 — Articulator Arthroscopic Bur (November 21, 2025)
  • K252458 — Kyphoplasty Balloon Dilatation Catheters (November 3, 2025)
  • K252594 — UltraGuideCTR® image guided soft tissue release system (September 29, 2025)
  • K243774 — ELID (Endoscopic Less Invasive Decompression) System (August 27, 2025)
  • K241990 — SpineSite Endoscope System (July 30, 2025)
  • K243602 — Arthrex Spine Endoscope (May 16, 2025)
  • K242417 — VECTR – Video Endoscopic Carpal Tunnel Release System (December 11, 2024)