510(k) K123441
- Device
- STRYKER CROSSFLOW ARTHROSCOPY PUMP
- Applicant
- Stryker Endoscopy
- 510(k) number
- K123441
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-01-09
- Date received
- 2012-11-08
- 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
- Yes
Applicant Contact#
- Contact
- KEVIN POTGIETER
- Address
- 5900 Optical Ct. San Jose CA US 95138 95138
FDA Registration Numbers#
- 3010097171
- 3001239363
- 1424263
- 3010220595
- 3030446844
- 3006142527
- 3011373951
- 3035858921
- 3004111573
- 2243757
- 1056128
- 3020163307
- 2916714
- 3007499195
- 3003704957
- 3011163668
- 3017210488
- 3010692967
- 3013479847
- 3014579161
- 3017196117
- 3013176080
- 3015542154
- 3010356635
- 3008058135
- 3006498370
- 3027339877
- 1319639
- 3009509485
- 2246552
- 1221826
- 1000517406
- 1483278
- 3030153385
- 3008837339
- 9613793
- 3015316279
- 3010049501
- 3009888740
- 3016112537
- 9681191
- 1055236
- 1928237
- 3008110533
- 3005382983
- 1720929
- 3009756153
- 3003678543
- 3016842760
- 9612501
- 3011944170
- 2648623
- 3034676720
- 3009988302
- 9614434
- 3015225571
- 1226544
- 3002806603
- 3005941719
- 2951215
- 3007024186
- 1047429
- 3011989923
- 3016667340
- 3015399803
- 3004464325
- 3024021261
- 3009394448
- 3021226419
- 3007738736
- 1222928
- 3010202439
- 3010071016
- 3014725904
- 3010264076
- 2320762
- 3000270450
- 1526439
- 2953359
- 3013404959
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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