510(k) K910587
- Device
- MINISCOPE
- Applicant
- CITATION MEDICAL CORP.
- 510(k) number
- K910587
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-05-13
- Date received
- 1991-02-12
- Regulation
- 888.1100
- Classification name
- Arthroscope
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- F WADDELL
- Address
- 230 Edison Way Reno NV US 89502 89502
FDA Registration Numbers#
- 2084346
- 3004142400
- 2523676
- 3016050940
- 3007499195
- 3010692967
- 1422634
- 3005820796
- 3005677016
- 3018242561
- 2020550
- 9680718
- 9611102
- 3001239363
- 1836161
- 3008868758
- 9611503
- 3010509633
- 2936485
- 1423662
- 8044091
- 3009882675
- 3018821071
- 3000286616
- 3012329552
- 3010419931
- 1000517406
- 2522206
- 3014644276
- 3008573567
- 3008058135
- 1032347
- 9614434
- 1054241
- 3014202166
- 3008959444
- 2650143
- 1018470
- 3016789487
- 3020163307
- 3016851379
- 3005596514
- 3014232239
- 3027262786
- 8043980
- 3001556604
- 3010264076
- 2183744
- 3014004349
- 3001592626
- 3009756153
- 2649614
- 1047429
- 3005083075
- 3015151147
- 3013023255
- 3030926959
- 3015399803
- 1834331
- 3015276780
- 3021336182
- 3006891611
- 3011489618
- 1625507
- 1483278
- 3015316279
- 3016678045
- 3015976667
- 2916714
- 3004111573
- 3009704301
- 3005382983
- 9681477
- 3005528784
- 3011944170
- 3014725904
- 3010898856
- 3010701628
- 3009973505
Source Documents#
510(k) summary PDF not indicated by FDA
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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