HSW GmbH Arthroscope
FDA 510(k) K962075 · Henke Sass Wolf of America, Inc.
510(k) numberK962075
Submission
- Device name
- HSW GmbH Arthroscope
- Applicant
- Henke Sass Wolf of America, Inc.
Southbridge, MA, US - Received
- May 28, 1996
- Decision date
- January 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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).
Other 510(k)s with product code HRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Hand Biomechanics Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K080560 | Henke Sass Wolf of America ArthroscopeHRX · Traditional | 03/18/2008SE |
| K050163 | Henke Sass Wolf of America Bariatric LaparoscopeGCJ · Traditional | 03/24/2005SE |
| K030572 | Henke Sass Wolf of America NasopharyngoscopeEOB · Traditional | 04/01/2003SE |
| K013611 | Henke Sass Wolf Saphenous Vein LaparoscopeGCJ · Traditional | 02/01/2002SE |
| K991563 | Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation…HIH · Traditional | 10/13/1999SE |
| K983067 | Fine-JectFMI · Traditional | 10/30/1998SE |
| K981751 | Sinuscope and AccessoriesEOB · Traditional | 08/13/1998SE |
| K941541 | HSV Laparoscopy SetGCJ · Traditional | 05/16/1994SE |
Questions and answers
When was HSW GmbH Arthroscope cleared by the FDA?
HSW GmbH Arthroscope (K962075) received a 510(k) decision of Substantially Equivalent on January 17, 1997, 234 days after the submission was received.
What is the product code of K962075?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.