Arthrex Arthroscope
510(k) K921119
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921119 | Date15 Apr 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Arthrex Arthroscope is an arthroscope (device type: HRX), a rigid endoscope used for visualizing, diagnosing, and treating joint conditions. It provides high-resolution imaging of internal joint structures, enabling minimally invasive procedures such as debridement, meniscectomy, or ligament repair. The device is designed for arthroscopic surgery, particularly in orthopedic applications, where precision and clarity are critical.
This autoclavable arthroscope is supplied sterile and intended for single-use or repeated sterilization cycles, as indicated by its durable construction. It is compatible with the Synergy camera systems and features a quick-connect interface for secure sheath attachment, available in multiple diameters to accommodate various surgical needs. The device is regulated under FDA 510(k) clearance (K921119) and falls under the Orthopedic Advisory Committee’s review category, adhering to traditional clearance pathways.
Other devices from Arthrex, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Arthrex Arthroscope used for in orthopedic surgery?
The Arthrex Arthroscope is designed for visualizing, diagnosing, and treating joint conditions through minimally invasive arthroscopic procedures. It enables surgeons to perform tasks such as debridement, meniscectomy, or ligament repair with high-resolution imaging, ensuring precision in orthopedic surgeries where clarity and accuracy are critical.
Is the Arthrex Arthroscope autoclavable, and how does that affect its use?
Yes, the Arthrex Arthroscope is autoclavable, meaning it can withstand repeated sterilization cycles. This durable construction allows for single-use applications or reuse after proper sterilization, providing flexibility depending on clinical protocols and infection control requirements.
What camera systems is the Arthrex Arthroscope compatible with?
The Arthrex Arthroscope is specifically designed to work with the Arthrex Synergy camera systems. This compatibility ensures seamless integration for high-quality imaging during arthroscopic procedures, enhancing surgical workflow and precision.
Are there different sizes or diameters available for the Arthrex Arthroscope?
Yes, the Arthrex Arthroscope is available in multiple diameters to accommodate various surgical needs. The quick-connect interface also allows for easy attachment of compatible sheaths, ensuring versatility for different joint procedures.
How is the Arthrex Arthroscope supplied, and what does that mean for clinical use?
The Arthrex Arthroscope is supplied sterile, which reduces the risk of infection and simplifies preparation for use. This sterile packaging ensures readiness for immediate deployment in surgical settings, adhering to clinical best practices for cleanliness and safety.