HRX

Arthroscope

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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (20)

Last three years. Most recent: 2026-08-28.

NumberDecision dateApplicantDevice name
K2602032026-08-28Beijing Fule Science & Technology DeveFule Vertebroplasty Balloon Catheter summary
K2541032026-08-26Karl Storz SE & CO. KGHOPKINS Telescopes for Arthroscopy summary
K2527902026-05-26Clarus Medical, LLCDigital ClarusScope System and Digital NeuroPEN Syst summary
K2535232026-04-16Spinal SimplicityFreedom DS™ Decompression System summary
K2525462026-03-12Allevion Medical, LLCVantageTM Lumbar Decompression Kit summary
K2532172025-12-23Medimaging Integrated Solution, Inc (MMiiS Horus Arthroscope (EJA 100); MiiS Horus Endosc summary
K2507952025-12-05W.O.M. World of Medicine GmbHPUREVUE™ FMS summary
K2526662025-11-21Joint Preservation Innovations, LLCArticulator Arthroscopic Bur summary
K2524582025-11-03Shanghai Lange Medtech Co., Ltd.Kyphoplasty Balloon Dilatation Catheters summary
K2520202025-10-15Hand Biomechanics Lab, Inc.TunnelVision Endoscopic Soft Tissue Release System a summary
K2525942025-09-29Sonex HealthUltraGuideCTR® image guided soft tissue release syst summary
K2437742025-08-27Lesspine InnovationsELID (Endoscopic Less Invasive Decompression) System summary
K2419902025-07-30Hydrocision, Inc.SpineSite Endoscope System summary
K2436022025-05-16Arthrex, Inc.Arthrex Spine Endoscope summary
K2424172024-12-11Rafael Medical Devices, LLCVECTR – Video Endoscopic Carpal Tunnel Release Syste summary
K2430202024-12-02Intravu, Inc.MIDASVu summary
K2338002024-05-06Vertos Medical, Inc.Vertos mild Device Kit (MDK-0002) summary
K2405352024-04-25Clarus Medical, LLCDigital ClarusScope System; Digital NeuroPEN System summary
K2336752024-02-26DePuy Mitek, Inc.FMS VUE™ Fluid Management and Tissue Debridement Sys summary
K2331152024-02-06E Surgical, LLCHawkeye Control Unit with Eyas Endoscope summary
Official FDA classification page: HRX
Classification and pathway per current FDA publications. Data from openFDA (CC0).