HRX
- Product code
- HRX
- Device name
- Arthroscope
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.1100
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 683
FDA classification 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).
510(k) clearances, last 3 years (20)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K260203 | 2026-08-28 | Beijing Fule Science & Technology Deve | Fule Vertebroplasty Balloon Catheter summary |
| K254103 | 2026-08-26 | Karl Storz SE & CO. KG | HOPKINS Telescopes for Arthroscopy summary |
| K252790 | 2026-05-26 | Clarus Medical, LLC | Digital ClarusScope System and Digital NeuroPEN Syst summary |
| K253523 | 2026-04-16 | Spinal Simplicity | Freedom DS Decompression System summary |
| K252546 | 2026-03-12 | Allevion Medical, LLC | VantageTM Lumbar Decompression Kit summary |
| K253217 | 2025-12-23 | Medimaging Integrated Solution, Inc (M | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endosc summary |
| K250795 | 2025-12-05 | W.O.M. World of Medicine GmbH | PUREVUE FMS summary |
| K252666 | 2025-11-21 | Joint Preservation Innovations, LLC | Articulator Arthroscopic Bur summary |
| K252458 | 2025-11-03 | Shanghai Lange Medtech Co., Ltd. | Kyphoplasty Balloon Dilatation Catheters summary |
| K252020 | 2025-10-15 | Hand Biomechanics Lab, Inc. | TunnelVision Endoscopic Soft Tissue Release System a summary |
| K252594 | 2025-09-29 | Sonex Health | UltraGuideCTR® image guided soft tissue release syst summary |
| K243774 | 2025-08-27 | Lesspine Innovations | ELID (Endoscopic Less Invasive Decompression) System summary |
| K241990 | 2025-07-30 | Hydrocision, Inc. | SpineSite Endoscope System summary |
| K243602 | 2025-05-16 | Arthrex, Inc. | Arthrex Spine Endoscope summary |
| K242417 | 2024-12-11 | Rafael Medical Devices, LLC | VECTR Video Endoscopic Carpal Tunnel Release Syste summary |
| K243020 | 2024-12-02 | Intravu, Inc. | MIDASVu summary |
| K233800 | 2024-05-06 | Vertos Medical, Inc. | Vertos mild Device Kit (MDK-0002) summary |
| K240535 | 2024-04-25 | Clarus Medical, LLC | Digital ClarusScope System; Digital NeuroPEN System summary |
| K233675 | 2024-02-26 | DePuy Mitek, Inc. | FMS VUE Fluid Management and Tissue Debridement Sys summary |
| K233115 | 2024-02-06 | E Surgical, LLC | Hawkeye Control Unit with Eyas Endoscope summary |
Official FDA classification page: HRX
Classification and pathway per current FDA publications. Data from openFDA (CC0).