Ksea Powershaver System S2
FDA 510(k) K030009 · Karl Storz Endoscopy
510(k) numberK030009
Submission
- Device name
- Ksea Powershaver System S2
- Applicant
- Karl Storz Endoscopy
Culver City, CA, US - Received
- January 2, 2003
- Decision date
- April 2, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRX – Arthroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1100
- Specialty
- Orthopedic
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).
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| K260203 | Fule Vertebroplasty Balloon CatheterHRX · Traditional | Beijing Fule Science & Technology Development… | 08/28/2026SE |
| K254103 | HOPKINS Telescopes for ArthroscopyHRX · Traditional | Karl Storz SE & CO. KG | 08/26/2026SE |
| K252790 | Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional | Clarus Medical, LLC | 05/26/2026SE |
| K253523 | Freedom DS Decompression SystemHRX · Traditional | Spinal Simplicity | 04/16/2026SE |
| K252546 | VantageTM Lumbar Decompression KitHRX · Traditional | Allevion Medical, LLC | 03/12/2026SE |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 12/23/2025SE |
| K250795 | Purevue FMSHRX · Traditional | W.O.M. World of Medicine GmbH | 12/05/2025SE |
| K252666 | Articulator Arthroscopic BurHRX · Traditional | Joint Preservation Innovations, LLC | 11/21/2025SE |
| K252458 | Kyphoplasty Balloon Dilatation CathetersHRX · Traditional | Shanghai Lange Medtech Co., Ltd. | 11/03/2025SE |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional | Hand Biomechanics Lab, Inc. | 10/15/2025SE |
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| K023924 | Autocon II 200 Electrosurgical GeneratorGEI · Traditional | 02/21/2003SE |
| K023187 | Ksea SpinoscopeHRX · Traditional | 12/02/2002SE |
| K011700 | Modulith SLK LithotripterLNS · Traditional | 08/16/2002SE |
| K021776 | Ksea Quadro SwitchOCX · Traditional | 08/15/2002SE |
| K013107 | Bioabsorbable Interference Screw MegafixHWC · Traditional | 02/26/2002SE |
| K011841 | Ksea Sawahle Electromechanical MorcellatorGCJ · Traditional | 09/10/2001SE |
| K010569 | Ksea Universal Laparomat Laparoscopic Suction and Irrigation PumpGCJ · Traditional | 04/09/2001SE |
| K004037 | X-Ray System Xr-MxJAA · Traditional | 02/02/2001SE |
Questions and answers
When was Ksea Powershaver System S2 cleared by the FDA?
Ksea Powershaver System S2 (K030009) received a 510(k) decision of Substantially Equivalent on April 2, 2003, 90 days after the submission was received.
What is the product code of K030009?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.