510(k) K020083
- Device
- TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
- Applicant
- TUTA HEALTHCARE PTY LIMITED
- 510(k) number
- K020083
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-12
- Date received
- 2002-01-10
- 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
- OMID SOURESRAFIL
- Address
- 318-332 Burns Bay Rd. Ln. Cove Sydney Nsw AU 2066 2066
FDA Registration Numbers#
- 1221826
- 3020899789
- 3002579136
- 1320894
- 3010432890
- 3004598644
- 3006950086
- 3015967359
- 1721686
- 2032677
- 3025603301
- 3004748528
- 3013700547
- 2650143
- 3012809732
- 3034676720
- 3013404959
- 3014725904
- 1045254
- 3009756153
- 2032521
- 1721504
- 9611112
- 3043226252
- 9615782
- 9611102
- 3006546082
- 2919128
- 3009394448
- 3014202166
- 3004194523
- 1220246
- 2320762
- 3007495879
- 1720929
- 9615001
- 3017406274
- 3047841690
- 3004361445
- 3016112537
- 1123169
- 3010760216
- 3008215723
- 9680718
- 3000270450
- 3016667340
- 1450662
- 3009350690
- 2647346
- 3021226419
- 3004111573
- 1055236
- 3003704957
- 3030447506
- 2011171
- 3012494290
- 8043903
- 3003935342
- 3007305485
- 9611503
- 3015806723
- 3008868758
- 3010049501
- 1061124
- 3010399422
- 3011989923
- 3012322232
- 3009888740
- 3010132111
- 3014200871
- 9610617
- 3010707607
- 3008959444
- 8010418
- 3010509633
- 1048735
- 3025318945
- 3010898856
- 3016438694
Source Documents#
Other 510(k) Records For Product Code HRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263208 | Vantage Lumbar Decompression Kit | SurGenTec, LLC | 2026-10-14 |
| K260156 | TruVision Single-Use 1.9mm Arthroscopy System | Nexus CMF, LLC | 2026-10-09 |
| 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 |
Legacy Summary#
summary
FDA Review#
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