Identifiers
- 510(k) Number
- K093677 FDA 510(k)
- FDA Product Code
- HRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.1100 FDA 510(k)
- Regulation Number
- 888.1100 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
An arthroscope is a medical device used for visualizing the interior of joints during minimally invasive surgical procedures. This device is designed for endoscopic visualization in orthopedic applications.
The device is supplied as a reusable instrument requiring sterilization between uses, typically via autoclaving. It is indicated for use in operating room settings and has received FDA 510(k) clearance under product code HRX, with clearance granted on March 5, 2010, based on substantial equivalence to a predicate device.
Frequently asked questions
What is the STRYKER ARTHROSCOPE used for?
The STRYKER ARTHROSCOPE is used for visualizing the interior of joints during minimally invasive surgical procedures, specifically designed for endoscopic visualization in orthopedic applications as stated in the device description.
Is the STRYKER ARTHROSCOPE supplied sterile or non-sterile, and how is it prepared for use?
The device is supplied as a reusable instrument requiring sterilization between uses, typically via autoclaving, meaning it is provided non-sterile and must be sterilized by the healthcare facility before each procedure.
What regulatory pathway was used for the STRYKER ARTHROSCOPE, and what is its clearance identifier?
The STRYKER ARTHROSCOPE received FDA 510(k) clearance under product code HRX, with clearance granted on March 5, 2010, based on substantial equivalence to a predicate device, as indicated by the K-number K093677 and decision code SESE.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Endoscopy | Stryker, Stryker Autoclavable Arthroscope, 4mm x 30° | 502-444-030, Stryker Arthroscopy Product Guide, Stryker 1188 Complete Arthroscopy System | United Endoscopy
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093677 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Endoscopy
Sources (1)
- FDA 510(k) K093677 24 fields · synced Sep 25, 2026