FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
K Number: K252020
·
Decision Oct 15, 2025
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
9
Review Days
107
Basic Information
- Device Name
- TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
- K Number
- K252020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hand Biomechanics Lab, Inc.
- Date Received
- June 30, 2025
- Decision Date
- October 15, 2025
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRX), ordered by most recent decision date.
Digital ClarusScope System and Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom DS Decompression System
FDA 510(k)
FDA Class 2
·Orthopedic
VantageTM Lumbar Decompression Kit
FDA 510(k)
FDA Class 2
·Orthopedic
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
FDA 510(k)
FDA Class 2
·Orthopedic
PUREVUE FMS
FDA 510(k)
FDA Class 2
·Orthopedic
Articulator Arthroscopic Bur
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Hand Biomechanics Lab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222490 | HBL Blade Assembly | Nov 14, 2022 | Substantially Equivalent |
| K181192 | PIP Fix | Oct 22, 2018 | Substantially Equivalent |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | Jan 9, 2008 | Substantially Equivalent |
| K033112 | WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS | Nov 5, 2003 | Substantially Equivalent |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS | Jun 10, 2003 | Substantially Equivalent |
| K992970 | DIGIT WIDGET | Nov 8, 1999 | Substantially Equivalent |
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 | Feb 12, 1999 | Substantially Equivalent |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Dec 22, 1994 | Substantially Equivalent |