TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
FDA 510(k) K252020 · Hand Biomechanics Lab, Inc.
510(k) numberK252020
Submission
- Device name
- TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
- Applicant
- Hand Biomechanics Lab, Inc.
Sacramento, CA, US - Received
- June 30, 2025
- Decision date
- October 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRX – Arthroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1100
- Specialty
- Orthopedic
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).
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|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon CatheterHRX · Traditional | Beijing Fule Science & Technology Development… | 08/28/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | Karl Storz SE & CO. KG | 08/26/2026SE |
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | Clarus Medical, LLC | 05/26/2026SE |
| K253523 | Freedom DS Decompression SystemHRX · Traditional | Spinal Simplicity | 04/16/2026SE |
| K252546 | VantageTM Lumbar Decompression KitHRX · Traditional | Allevion Medical, LLC | 03/12/2026SE |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 12/23/2025SE |
| K250795 | Purevue FMSHRX · Traditional | W.O.M. World of Medicine GmbH | 12/05/2025SE |
| K252666 | Articulator Arthroscopic BurHRX · Traditional | Joint Preservation Innovations, LLC | 11/21/2025SE |
| K252458 | Kyphoplasty Balloon Dilatation CathetersHRX · Traditional | Shanghai Lange Medtech Co., Ltd. | 11/03/2025SE |
| K252594 | UltraGuideCTR® image guided soft tissue release systemHRX · Traditional | Sonex Health | 09/29/2025SE |
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| K033112 | Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NSKTT · Traditional | 11/05/2003SE |
| K030519 | Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNSJEC · Traditional | 06/10/2003SE |
| K992970 | Digit WidgetJDW · Traditional | 11/08/1999SE |
| K984442 | Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147JEC · Traditional | 02/12/1999SE |
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Questions and answers
When was TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly cleared by the FDA?
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (K252020) received a 510(k) decision of Substantially Equivalent on October 15, 2025, 107 days after the submission was received.
What is the product code of K252020?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.