510(k) K223244
- Device
- Pristine Arthroscopic Visualization System
- Applicant
- Pristine Surgical
- 510(k) number
- K223244
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-21
- Date received
- 2022-10-20
- Regulation
- 888.1100
- Classification name
- Arthroscope
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stewart B Davis
- Address
- Brady Sullivan Tower, 6th Floor, 1750 Elm St. Manchester NH US 03104 03104
FDA Registration Numbers#
- 3008044552
- 3007499195
- 3016099036
- 2084346
- 2320762
- 3011401113
- 3003935342
- 3014615697
- 2243757
- 3010701628
- 3004893332
- 3010356635
- 3009756153
- 1017294
- 9615001
- 1649518
- 3033589330
- 1625507
- 9610612
- 9614434
- 2032098
- 3010032903
- 9617616
- 3000286616
- 3033536319
- 3006546082
- 3008583793
- 3009702671
- 1030451
- 9612052
- 2648623
- 3002579136
- 3013557562
- 3041915827
- 9680721
- 3003755939
- 1650907
- 3010097171
- 3009882675
- 1226544
- 3003604053
- 3030446844
- 1000517406
- 3015453963
- 3018242561
- 1836161
- 3020163307
- 3004920696
- 2183744
- 3013479847
- 3009394448
- 3009973505
- 3035366890
- 3024021261
- 3017396949
- 3013700547
- 3010120148
- 3025318945
- 2183911
- 3010132111
- 3009538961
- 3017210488
- 3012536737
- 3014232239
- 3012790575
- 3006498370
- 1219602
- 3014342096
- 3016727307
- 3006849754
- 3009704301
- 3010509633
- 3015967359
- 3012494290
- 3010049501
- 3030153385
- 3024788684
- 3021477808
- 3002807314
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 |