Sight-Plus Arthroscope
by American Medical Concepts, Inc.
510(k) K925226
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925226 | Date28 Jul 1993 | 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- Withdrawn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 Sight-Plus Arthroscope is an arthroscope, a device used for visual examination, diagnosis, and treatment of joint cavities. It is designed to provide direct visualization of internal joint structures, such as the knee, shoulder, or elbow, through minimally invasive techniques. This device allows surgeons to identify and address issues such as tears, inflammation, or degenerative changes within the joint space. Its optical system enables real-time imaging, facilitating precise surgical interventions.
The Sight-Plus Arthroscope is supplied as a reusable medical instrument and is intended for use in sterile surgical settings. It is classified under product code HRX and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The device is regulated under the traditional 510(k) review pathway, with clearance granted in 1993. No specific MRI safety information is provided, and its use requires adherence to standard surgical protocols and sterility procedures.
Questions
AI-generated answers, 1 Oct 2026
What is the Sight-Plus Arthroscope used for?
The Sight-Plus Arthroscope is designed for visual examination, diagnosis, and treatment of joint cavities such as the knee, shoulder, or elbow. It enables surgeons to directly observe internal joint structures—like tears, inflammation, or degenerative changes—through minimally invasive techniques. Its optical system provides real-time imaging, supporting precise surgical interventions.
Is the Sight-Plus Arthroscope reusable or single-use?
The Sight-Plus Arthroscope is supplied as a reusable medical instrument. It is intended for use in sterile surgical settings, requiring adherence to standard sterilization protocols between procedures to ensure safety and efficacy.
What regulatory pathway does the Sight-Plus Arthroscope follow?
The Sight-Plus Arthroscope is regulated under the traditional 510(k) review pathway and received FDA clearance in 1993. It was classified as substantially equivalent to a predicate device, with clearance granted by the Orthopedic (OR) Advisory Committee.
What product code and classification does the Sight-Plus Arthroscope fall under?
The Sight-Plus Arthroscope is classified under product code HRX, which categorizes it as an arthroscopic device. This classification aligns with its use for diagnostic and therapeutic procedures within joint cavities.
Are there any special considerations for storage or handling of the Sight-Plus Arthroscope?
While specific storage instructions are not detailed in the provided data, the Sight-Plus Arthroscope is intended for reusable use in sterile surgical settings. Proper cleaning, sterilization, and maintenance between procedures are critical to preserve its functionality and prevent contamination. Always follow manufacturer guidelines for handling and storage.