510(k) K030009
- Device
- KSEA POWERSHAVER SYSTEM S2
- Applicant
- KARL STORZ ENDOSCOPY
- 510(k) number
- K030009
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-04-02
- Date received
- 2003-01-02
- Regulation
- 888.1100
- Classification name
- Arthroscope
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code HRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243020 | MIDASVu | Intravu, Inc. | 2024-12-02 |
| K233800 | Vertos mild Device Kit (MDK-0002) | Vertos Medical, Inc. | 2024-05-06 |
Legacy Summary#
summary
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