Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

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)
20
Summaries archived here
17 (direct download)
510(k) clearances (all years, FDA)
683 (all years; only the last 3 years are listed here)

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

17 summaries are archived here for direct download.

Official FDA classification page: HRX
Classification and pathway per current FDA publications. Data from openFDA (CC0).