HRX — Arthroscope Class II
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 |
|---|---|---|---|
| K252546 | allevion medical | VantageTM Lumbar Decompression Kit | March 12, 2026 |
| K253217 | medimaging integrated solution, inc (miis) | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet ( | December 23, 2025 |
| K250795 | w.o.m. world of medicine | PUREVUE FMS | December 5, 2025 |
| K252666 | joint preservation innovations | Articulator Arthroscopic Bur | November 21, 2025 |
| K252458 | shanghai lange medtech co | Kyphoplasty Balloon Dilatation Catheters | November 3, 2025 |
| K252020 | hand biomechanics lab | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | October 15, 2025 |
| K252594 | sonex health | UltraGuideCTR® image guided soft tissue release system | September 29, 2025 |
| K243774 | lesspine innovations | ELID (Endoscopic Less Invasive Decompression) System | August 27, 2025 |
| K241990 | hydrocision | SpineSite Endoscope System | July 30, 2025 |
| K243602 | arthrex | Arthrex Spine Endoscope | May 16, 2025 |
| K242417 | rafael medical devices | VECTR Video Endoscopic Carpal Tunnel Release System | December 11, 2024 |
| K243020 | intravu | MIDASVu | December 2, 2024 |
| K233800 | vertos medical | Vertos mild Device Kit (MDK-0002) | May 6, 2024 |
| K240535 | clarus medical | Digital ClarusScope System; Digital NeuroPEN System | April 25, 2024 |
| K233675 | depuy mitek | FMS VUE Fluid Management and Tissue Debridement System | February 26, 2024 |
| K233115 | e surgical | Hawkeye Control Unit with Eyas Endoscope | February 6, 2024 |
| K223709 | jiangsu changmei medtech co | Kyphoplasty Balloon Catheter | August 16, 2023 |
| K221142 | ok medinetkorea co | Kyphoplasty Balloon System | April 21, 2023 |
| K221919 | hemodia | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | March 9, 2023 |
| K223406 | microaire surgical instruments | SmartRelease Endoscopic Soft Tissue Release System | February 2, 2023 |