510(k) K083161
- Device
- ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)
- Applicant
- CONMED LINVATEC
- 510(k) number
- K083161
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-27
- Date received
- 2008-10-27
- 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
- SUE DAUTERMAN
- Address
- 11311 Concept Blvd. Largo FL US 33773 33773
FDA Registration Numbers#
- 3016851379
- 1650907
- 3008583793
- 8010374
- 3007955117
- 2531321
- 3004464325
- 3010097171
- 3006891611
- 3013557562
- 3016727307
- 3010032903
- 1222997
- 3013944123
- 1221934
- 3011401113
- 3021226419
- 3011024991
- 3011163668
- 3018821071
- 3020899789
- 3001556604
- 3010120148
- 3008959444
- 2011171
- 1423662
- 3005254598
- 3044156918
- 3009882675
- 3009509485
- 1928237
- 2031093
- 3044858680
- 3015183635
- 3005677016
- 9615782
- 3014725904
- 3006946276
- 3013298431
- 2528981
- 3005180920
- 8010177
- 1647149
- 1030451
- 3007867838
- 3030926959
- 3009417901
- 2648666
- 3004194523
- 3018094310
- 1416980
- 3012322232
- 3009394448
- 9681477
- 2183911
- 3014388471
- 3035642068
- 3013176080
- 3014315560
- 3020704423
- 3016438694
- 3003604053
- 2183449
- 3021477808
- 1824199
- 3005596514
- 3009475067
- 8010349
- 9611102
- 9617601
- 3011373951
- 9612501
- 9680718
- 3015309643
- 1030489
- 3010707607
- 1836161
- 3015399803
- 3012790575
- 1526439
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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