510(k) K260156
- Device
- TruVision Single-Use 1.9mm Arthroscopy System
- Applicant
- Nexus CMF, LLC
- 510(k) number
- K260156
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-09
- Date received
- 2026-01-20
- 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
- Wittwer Tiffini
- Address
- 2825 E. Cottonwood Pkwy. Suite 330 Salt Lake City UT US 84121 84121
FDA Registration Numbers#
- 3017196117
- 3030926959
- 3011277660
- 9681574
- 2243757
- 3010432890
- 1056128
- 2011171
- 3012329552
- 3025603301
- 3035642068
- 1219602
- 2936485
- 3015806723
- 3017565094
- 3009475067
- 1422078
- 3011050570
- 3009882675
- 2085947
- 3020978007
- 8030607
- 3016099036
- 3003704957
- 3015539532
- 1643264
- 3044905149
- 3004111573
- 3007955117
- 8010877
- 9613793
- 3009746061
- 1030451
- 3009973505
- 3015231789
- 3010356635
- 3012494290
- 3018821071
- 1424263
- 3015151147
- 3017210488
- 3009988302
- 3023155873
- 9615001
- 2531321
- 2648623
- 3009499159
- 3036756245
- 2032830
- 3004194523
- 9515015
- 3011989923
- 3016438694
- 1643817
- 3006561161
- 2183911
- 3016851379
- 3019766696
- 3010071016
- 3005910889
- 3002808022
- 1221934
- 3013404959
- 9615782
- 9681191
- 3009704301
- 3011543740
- 1724474
- 3021477808
- 3009018440
- 1017294
- 3017396949
- 3005528784
- 1220477
- 3008837339
- 2032098
- 3014388471
- 3010331645
- 3002579136
Source Documents#
Other 510(k) Records For Product Code HRX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. | 2026-08-28 |
| 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 |