510(k) K972768
- Device
- BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM
- Applicant
- BLACKSTONE MEDICAL, INC.
- 510(k) number
- K972768
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-09-25
- Date received
- 1997-07-24
- 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
- JOSEPH S MOONEY
- Address
- 90 Brookdale Dr. Springfield MA US 01104 01104
FDA Registration Numbers#
- 3003935342
- 3015974593
- 3007421149
- 3041915827
- 9612052
- 3009882675
- 1319639
- 3013479847
- 3011683674
- 3014004349
- 8040510
- 9617616
- 3016842760
- 3014388471
- 3016678045
- 3016789487
- 3003902757
- 9612501
- 9610617
- 3011024991
- 3012818475
- 3007993775
- 2084346
- 3013700547
- 8030607
- 8010374
- 3002808022
- 8010418
- 3013176080
- 9615782
- 3015151147
- 1061124
- 3005596514
- 3006950086
- 8010298
- 3004111573
- 3004361445
- 3014644276
- 2183449
- 2649614
- 3009328501
- 3035642068
- 3017196117
- 3017396949
- 3005254598
- 3010071016
- 3013247477
- 3012790575
- 1220246
- 3012536737
- 9611102
- 1720929
- 3020163307
- 1526534
- 2951215
- 2648666
- 8010877
- 3012494290
- 3013557562
- 3030446844
- 1834331
- 2020601
- 3006524618
- 3014315560
- 3009888740
- 3012809732
- 3015173212
- 3011277660
- 3020899789
- 3014725904
- 3010432890
- 3008110533
- 3007499195
- 1418479
- 2320762
- 3007867838
- 1320894
- 1650907
- 3008812560
- 3012322232
Source Documents#
Other 510(k) Records For Product Code HRX #
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|---|---|---|---|
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| K254103 | HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG | 2026-08-26 |
| 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 |
Legacy Summary#
summary
FDA Review#
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