Xenon Light Source for Endoscopic Procedures
FDA 510(k) K863986 · American Edwards Laboratories
510(k) numberK863986
Submission
- Device name
- Xenon Light Source for Endoscopic Procedures
- Applicant
- American Edwards Laboratories
Santa Ana, CA, US - Received
- October 14, 1986
- Decision date
- October 31, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K873485 | Edslab (R) Occlusion Balloon CatheterDQY · Traditional | 12/03/1987SE |
| K872596 | Trantec Disposable Pressure TRANS.53-600/F/F30DRS · Traditional | 09/30/1987SE |
| K872529 | Thermodilution Cardiac Output Computer, Mod. COM-2DXG · Traditional | 09/15/1987SE |
| K870444 | Homepro II Volumetric Infusion PumpFRN · Traditional | 04/17/1987SE |
| K864997 | Medtrac VP Volumetric Infusion PumpFRN · Traditional | 02/27/1987SE |
| K864330 | Shear Force GaugeDXE · Traditional | 01/06/1987SE |
| K862724 | Vein Valve CutterDQY · Traditional | 01/02/1987SE |
| K864155 | Modification of Carpentier-Edwards BioprosthesisDTJ · Traditional | 11/20/1986SE |
| K863596 | Chin-Fogarty Inflation DeviceDXT · Traditional | 11/20/1986SE |
| K862872 | Flexible Visualization CatheterFEI · Traditional | 10/24/1986SE |
Questions and answers
When was Xenon Light Source for Endoscopic Procedures cleared by the FDA?
Xenon Light Source for Endoscopic Procedures (K863986) received a 510(k) decision of Substantially Equivalent on October 31, 1986, 17 days after the submission was received.
What is the product code of K863986?
The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.