510(k) K260203
- Device
- Fule Vertebroplasty Balloon Catheter
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd.
- 510(k) number
- K260203
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-28
- Date received
- 2026-01-23
- Regulation
- 888.1100
- Classification name
- Arthroscope
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Xiaoliang Chen
- Address
- #50, Mafang W. Industry Zone, Pinggu District Beijing CN 101204 101204
FDA Registration Numbers#
- 3002808022
- 3013557562
- 3007305485
- 1061124
- 3001556604
- 3002807112
- 3011277660
- 3015539532
- 3014725904
- 1030489
- 1032347
- 1834331
- 3008215723
- 8043980
- 1416980
- 3006946276
- 1221826
- 3007024186
- 3015231789
- 3009746061
- 3006561161
- 3010760216
- 3003902757
- 3006946348
- 3010399422
- 3002907620
- 3012883081
- 1055236
- 3003755939
- 3034676720
- 1018470
- 3010692967
- 8010877
- 3003935342
- 3044905149
- 2084346
- 3015219237
- 3020978007
- 1721504
- 9680001
- 1054241
- 8010298
- 3013517171
- 3033509898
- 1625507
- 3014023545
- 3005977257
- 3025603301
- 3010707607
- 3019766696
- 9617616
- 3009538961
- 3015974593
- 3013404959
- 3007738736
- 9611112
- 9610612
- 3008868758
- 3003604053
- 3003704957
- 3016050940
- 3019269298
- 3010701628
- 3010097171
- 3006546082
- 3004194523
- 1048735
- 3006142527
- 3010071016
- 2032521
- 3002807310
- 1221485
- 3043226252
- 3007993775
- 3011373951
- 3012447612
- 3033043422
- 2183449
- 1649518
- 3015976667
Source Documents#
Other 510(k) Records For Product Code HRX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254103 | HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG | 2026-08-26 |
| K252790 | Digital ClarusScope System and Digital NeuroPEN System | Clarus Medical, LLC | 2026-05-26 |
| K253523 | Freedom DS™ Decompression System | Spinal Simplicity | 2026-04-16 |
| K252546 | VantageTM Lumbar Decompression Kit | Allevion Medical, LLC | 2026-03-12 |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | 2025-12-23 |
| K250795 | PUREVUE™ FMS | W.O.M. World of Medicine GmbH | 2025-12-05 |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | 2025-11-21 |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | 2025-11-03 |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2025-10-15 |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | 2025-09-29 |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | 2025-08-27 |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | 2025-07-30 |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | 2025-05-16 |
| K242417 | VECTR – Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | 2024-12-11 |
| K243020 | MIDASVu | Intravu, Inc. | 2024-12-02 |