Product code HRX
Current FDA Classification
- Device name
- Arthroscope
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.1100
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Definition
- Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K233115 | Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC | 2024-02-06 |
| K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei Medtech Co., Ltd. | 2023-08-16 |
| K221142 | Kyphoplasty Balloon System | OK Medinet Korea Co., Ltd. | 2023-04-21 |
| K221919 | DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets | Hemodia Sas | 2023-03-09 |
| K223406 | SmartRelease Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2023-02-02 |
| K223244 | Pristine Arthroscopic Visualization System | Pristine Surgical | 2022-12-21 |
| K222490 | HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2022-11-14 |
| K213978 | TELIGEN System | Medos International SARL | 2022-10-18 |
| K212636 | CORUS Spinal System-X | Providence Medical Technology, Inc. | 2021-10-15 |
| K212556 | mi-eye 3 needlescope with cannula, mi-tablet 3 | Trice Medical, Inc. | 2021-09-15 |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2021-06-24 |
| K203480 | DOUBLEFLO system | Hemodia Sas | 2021-04-05 |
| K202027 | Balex bone Expander System | Taeyeon Medical Co., Ltd. | 2021-02-03 |
| K193608 | EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG | 2021-01-15 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10845854041116 | POWERPRO | Conmed Corporation | 2026-03-24 |
| 04056702011970 | PUREVUE™ FMS | W.O.M. World of Medicine GmbH | 2026-03-10 |
| 04056702012137 | Tube set inflow 4-Spike adaptor | W.O.M. World of Medicine GmbH | 2026-03-10 |
| 04056702012113 | Tube set for suction, single-use | W.O.M. World of Medicine GmbH | 2026-03-10 |
| 04056702012090 | Tube set for vacuum, incl. filter, 30-day use | W.O.M. World of Medicine GmbH | 2026-03-10 |
| 04056702012076 | Patient tube for irrigation, single-use | W.O.M. World of Medicine GmbH | 2026-03-10 |
| 04056702012052 | Day use tube set for irrigation, pump part, 10 applications | W.O.M. World of Medicine GmbH | 2026-03-10 |
| 04056702012038 | Tube set for suction, 2-lines, single-use | W.O.M. World of Medicine GmbH | 2026-03-10 |
| 04056702012014 | Tube set for irrigation, single-use | W.O.M. World of Medicine GmbH | 2026-03-10 |
| 04056702011994 | Double pedal foot switch | W.O.M. World of Medicine GmbH | 2026-03-10 |
| 04056702011987 | Autoclavable remote control | W.O.M. World of Medicine GmbH | 2026-03-10 |
| 00763000956028 | Tubing Set | MEDTRONIC XOMED, INC. | 2026-02-14 |
| B382SD401290 | Surgical Direct | Surgical Direct, Inc. | 2026-02-09 |
| B382SD401490 | Surgical Direct | Surgical Direct, Inc. | 2026-02-09 |
| 08031497003825 | Mendec® Kypho Set Bilateral 20 mm | TECRES SPA | 2025-12-17 |
| 08031497003696 | Mendec® Kypho Set Monolateral 15 mm | TECRES SPA | 2025-12-17 |
| 08031497003818 | Mendec® Kypho Set Bilateral 15 mm | TECRES SPA | 2025-12-17 |
| 08031497003801 | Mendec® Kypho Set Bilateral 10 mm | TECRES SPA | 2025-12-17 |
| 08031497003702 | Mendec® Kypho Set Monolateral 20 mm | TECRES SPA | 2025-12-17 |
| 08031497003689 | Mendec® Kypho Set Monolateral 10 mm | TECRES SPA | 2025-12-17 |
| 06938695521026 | Drill | Shanghai Kinetic Medical Co., Ltd. | 2025-12-09 |
| 00841645122869 | ASSI | ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION | 2016-09-26 |
| 04042761010610 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761011068 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761011082 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761030373 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761030427 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761071482 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761071499 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |
| 04042761071505 | Olympus | OLYMPUS Winter & Ibe GmbH | 2016-09-21 |