510(k) K940144
- Device
- CLARUS PHOENIX ENDOSCOPE
- Applicant
- CLARUS MEDICAL SYSTEMS, INC.
- 510(k) number
- K940144
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-25
- Date received
- 1994-01-11
- 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
- GREGORY J MATHISON
- Address
- 1000 Boone Ave. N. #100 Minneapolis MN US 55427 55427
FDA Registration Numbers#
- 9681477
- 3015231789
- 1000517406
- 3011277660
- 3002808022
- 1048735
- 3006142527
- 2648666
- 3011373951
- 3001556604
- 3012495575
- 1226544
- 3013298431
- 3009417901
- 1721504
- 1650907
- 3009746061
- 3014342096
- 1319639
- 3007867838
- 3030153385
- 2919128
- 3014262693
- 3044905149
- 1064017
- 3006498370
- 3006546082
- 3025482817
- 3006946348
- 1526611
- 9680515
- 2031963
- 3014388471
- 3020704423
- 9612501
- 3014615697
- 3009499159
- 1643817
- 3009882675
- 3013404959
- 2183911
- 3025318945
- 3008058135
- 2649614
- 3020978007
- 1221826
- 9680718
- 3016667340
- 8043903
- 1824199
- 3025603301
- 3014479313
- 3005820796
- 3007738736
- 3010120148
- 3008837339
- 1834331
- 1928237
- 3018094310
- 9617616
- 1625507
- 3010419931
- 1222928
- 3004142400
- 3010763671
- 9615001
- 1720929
- 3008215723
- 3005941719
- 3007955117
- 3033043422
- 3007421149
- 1222997
- 3010032903
- 9617070
- 3013944123
- 8030607
- 1416980
- 3006891611
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#
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FDA Review#
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