510(k) K241990
- Device
- SpineSite Endoscope System
- Applicant
- Hydrocision, Inc.
- 510(k) number
- K241990
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-30
- Date received
- 2024-07-08
- 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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Mark Lewis
- Address
- 267 Boston Rd. Suite 28 North Billerica MA US 01862 01862
FDA Registration Numbers
- 1450662
- 3030926959
- 1416980
- 3009394448
- 3011277660
- 3004464325
- 3001239363
- 1421101
- 3015453963
- 2183744
- 3013188547
- 1834331
- 3012809732
- 9612074
- 3002807112
- 2032521
- 2649614
- 2031093
- 3030447506
- 3001556604
- 1643264
- 3011050570
- 3027262786
- 2085947
- 3003704957
- 3033589330
- 3006950086
- 3003678543
- 3027339877
- 8010877
- 1625507
- 3017210488
- 3002807314
- 1045254
- 2916714
- 8010177
- 3007113251
- 3007305485
- 3030733800
- 3033536319
- 3010331645
- 3006142527
- 3002808022
- 1030489
- 9613793
- 3015173212
- 1526611
- 3007421149
- 3009499159
- 2183449
- 9617616
- 3014579161
- 3014202166
- 8010418
- 1061927
- 3018242561
- 3005083075
- 2081135
- 3012790575
- 3007495879
- 3010432890
- 3030446844
- 3004734264
- 3005254598
- 3009973505
- 3004215117
- 3014200871
- 1221934
- 9614841
- 3012447612
- 9617601
- 3021336182
- 3020978007
- 3018821071
- 3009756153
- 9610617
- 3017396949
- 3014232239
- 1032347
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code HRX
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|---|---|---|---|
| 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 |
| 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 |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC | 2024-04-25 |
| K233675 | FMS VUE Fluid Management and Tissue Debridement System | DePuy Mitek, Inc. | 2024-02-26 |