HRX
- 产品代码
- HRX
- 器械名称
- Arthroscope
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.1100
- FDA 专业组
- Orthopedic
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 683 件
FDA 分类定义
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).
该代码近三年的 510(k)（20 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260203 | 2026-08-28 | Beijing Fule Science & Technology Deve | Fule Vertebroplasty Balloon Catheter 摘要 |
| K254103 | 2026-08-26 | Karl Storz SE & CO. KG | HOPKINS Telescopes for Arthroscopy 摘要 |
| K252790 | 2026-05-26 | Clarus Medical, LLC | Digital ClarusScope System and Digital NeuroPEN Syst 摘要 |
| K253523 | 2026-04-16 | Spinal Simplicity | Freedom DS Decompression System 摘要 |
| K252546 | 2026-03-12 | Allevion Medical, LLC | VantageTM Lumbar Decompression Kit 摘要 |
| K253217 | 2025-12-23 | Medimaging Integrated Solution, Inc (M | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endosc 摘要 |
| K250795 | 2025-12-05 | W.O.M. World of Medicine GmbH | PUREVUE FMS 摘要 |
| K252666 | 2025-11-21 | Joint Preservation Innovations, LLC | Articulator Arthroscopic Bur 摘要 |
| K252458 | 2025-11-03 | Shanghai Lange Medtech Co., Ltd. | Kyphoplasty Balloon Dilatation Catheters 摘要 |
| K252020 | 2025-10-15 | Hand Biomechanics Lab, Inc. | TunnelVision Endoscopic Soft Tissue Release System a 摘要 |
| K252594 | 2025-09-29 | Sonex Health | UltraGuideCTR® image guided soft tissue release syst 摘要 |
| K243774 | 2025-08-27 | Lesspine Innovations | ELID (Endoscopic Less Invasive Decompression) System 摘要 |
| K241990 | 2025-07-30 | Hydrocision, Inc. | SpineSite Endoscope System 摘要 |
| K243602 | 2025-05-16 | Arthrex, Inc. | Arthrex Spine Endoscope 摘要 |
| K242417 | 2024-12-11 | Rafael Medical Devices, LLC | VECTR Video Endoscopic Carpal Tunnel Release Syste 摘要 |
| K243020 | 2024-12-02 | Intravu, Inc. | MIDASVu 摘要 |
| K233800 | 2024-05-06 | Vertos Medical, Inc. | Vertos mild Device Kit (MDK-0002) 摘要 |
| K240535 | 2024-04-25 | Clarus Medical, LLC | Digital ClarusScope System; Digital NeuroPEN System 摘要 |
| K233675 | 2024-02-26 | DePuy Mitek, Inc. | FMS VUE Fluid Management and Tissue Debridement Sys 摘要 |
| K233115 | 2024-02-06 | E Surgical, LLC | Hawkeye Control Unit with Eyas Endoscope 摘要 |
FDA 官方分类页： HRX
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。