510(k) K093717
- Device
- C-MOR VISUALIZATION DEVICE
- Applicant
- AXIS SURGICAL TECHNOLOGIES, INC
- 510(k) number
- K093717
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-03-02
- Date received
- 2009-12-02
- 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
- No
Applicant Contact#
- Contact
- JAMES FARNWORTH
- Address
- 325 E. Middlefield Rd. Mountain View CA US 94043 94043
FDA Registration Numbers#
- 3011373951
- 3013497507
- 9614434
- 3004142400
- 3027339877
- 3015539532
- 3017210488
- 1720929
- 8010298
- 3017565094
- 3013188547
- 3044156918
- 3004920696
- 9617070
- 3015316279
- 2032521
- 3010356635
- 2031093
- 3016842760
- 3035642068
- 3009423112
- 3006498370
- 8010877
- 3007867838
- 3005180920
- 3015399803
- 3013479847
- 2648623
- 3004111573
- 3009475067
- 2648666
- 3010049501
- 3000286616
- 2523676
- 3010032903
- 3033589330
- 3021393544
- 1222997
- 1056128
- 3012883081
- 3035858921
- 3012358417
- 3025603301
- 3002907620
- 1043214
- 3004194523
- 3019766696
- 3018242561
- 3016438694
- 8040510
- 3011401113
- 9615782
- 3012494290
- 3006789154
- 3013700547
- 1320894
- 3044858680
- 3011683674
- 3016112537
- 2011171
- 2031963
- 1422634
- 3008215723
- 9681191
- 3015219237
- 3010132111
- 1123169
- 1423625
- 3030153385
- 3013176080
- 2936485
- 3015974593
- 1220477
- 3015276780
- 3009538961
- 9613793
- 3016099036
- 3010097171
- 3003755939
Source Documents#
Other 510(k) Records For Product Code HRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | 2024-05-06 |
Legacy Summary#
summary
FDA Review#
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