HRX — Arthroscope Class II
FDA product code HRX covers "Arthroscope", a Class II medical device regulated under 21 CFR 888.1100. Submissions are reviewed by the Orthopedic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HRX
- Device Class
- Class II
- Regulation Number
- 888.1100
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260203 | Beijing Fule Science And Technology Development Co | Fule Vertebroplasty Balloon Catheter | Aug 28, 2026 |
| K254103 | Karl Storz Se And Co. Kg | HOPKINS Telescopes for Arthroscopy | Aug 26, 2026 |
| K252790 | Clarus Medical | Digital ClarusScope System and Digital NeuroPEN System | May 26, 2026 |
| K253523 | Spinal Simplicity | Freedom DS Decompression System | Apr 16, 2026 |
| K252546 | Allevion Medical | VantageTM Lumbar Decompression Kit | Mar 12, 2026 |
| K253217 | Medimaging Integrated Solution, Inc (Miis) | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet ( | Dec 23, 2025 |
| K250795 | W.O.M. World Of Medicine | PUREVUE FMS | Dec 5, 2025 |
| K252666 | Joint Preservation Innovations | Articulator Arthroscopic Bur | Nov 21, 2025 |
| K252458 | Shanghai Lange Medtech Co | Kyphoplasty Balloon Dilatation Catheters | Nov 3, 2025 |
| K252020 | Hand Biomechanics Lab | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Oct 15, 2025 |
| K252594 | Sonex Health | UltraGuideCTR® image guided soft tissue release system | Sep 29, 2025 |
| K243774 | Lesspine Innovations | ELID (Endoscopic Less Invasive Decompression) System | Aug 27, 2025 |
| K241990 | Hydrocision | SpineSite Endoscope System | Jul 30, 2025 |
| K243602 | Arthrex | Arthrex Spine Endoscope | May 16, 2025 |
| K242417 | Rafael Medical Devices | VECTR Video Endoscopic Carpal Tunnel Release System | Dec 11, 2024 |
| K243020 | Intravu | MIDASVu | Dec 2, 2024 |
| K233800 | Vertos Medical | Vertos mild Device Kit (MDK-0002) | May 6, 2024 |
| K240535 | Clarus Medical | Digital ClarusScope System; Digital NeuroPEN System | Apr 25, 2024 |
| K233675 | Depuy Mitek | FMS VUE Fluid Management and Tissue Debridement System | Feb 26, 2024 |
| K233115 | E Surgical | Hawkeye Control Unit with Eyas Endoscope | Feb 6, 2024 |