510(k) K943356
- Device
- INCLUSIVE ENDOSCOPE
- Applicant
- DANEK MEDICAL, INC.
- 510(k) number
- K943356
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-10
- Date received
- 1994-07-12
- 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
- RICHARD W TREHARNE
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3014315560
- 9617601
- 3006561161
- 3010264076
- 3027339877
- 9611503
- 1226544
- 1721504
- 1320894
- 3010419931
- 3014479313
- 3011401113
- 1221934
- 3005528784
- 1647149
- 3003477135
- 3007867838
- 3004893332
- 3011050570
- 3027242374
- 3021566676
- 3008058135
- 3012447612
- 3004361445
- 3009538961
- 3002808022
- 3015976667
- 2528981
- 3002806603
- 9615782
- 3020163307
- 1222997
- 3010132111
- 9613793
- 3017565094
- 3018094310
- 1043214
- 1061927
- 3001239363
- 9681574
- 3011543740
- 8040510
- 3011683674
- 3008583793
- 3017210488
- 1720929
- 2084346
- 3009475067
- 3015276780
- 3004142400
- 9610773
- 3016851379
- 1423662
- 3004111573
- 3004194523
- 9611665
- 3006789154
- 9617070
- 1222928
- 3008573567
- 3003704957
- 3044858680
- 3016438694
- 3006546082
- 2085947
- 1422078
- 3014200871
- 3011489618
- 3015806723
- 9615001
- 3011373951
- 3010155661
- 3013404959
- 3007738736
- 3005596514
- 3007955117
- 3036756245
- 3010049501
- 3016112537
- 3021477808
Source Documents#
Other 510(k) Records For Product Code HRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260203 | Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. | 2026-08-28 |
| 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#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases