Ntech Arthroscope
by N-Tech Endoscopy, Inc. 510(k)
Active
510(k) K980599
Overview
The Ntech Arthroscope is a diagnostic and surgical device classified as an arthroscope, used for visual inspection and manipulation within joints. It enables minimally invasive procedures by transmitting images of internal joint structures to an external monitor, facilitating the diagnosis and treatment of musculoskeletal conditions such as tears, inflammation, or degenerative diseases. Its design allows for precise articulation and insertion into small joint spaces, including those of the knee, shoulder, or wrist.
Supplied as a reusable medical device, the Ntech Arthroscope is intended for use in sterile operating room environments. It is regulated under FDA 510(k) clearance (K980599) with a product code GCJ, classified under the Gastroenterology and Urology advisory committees. The device is not intended for single-use and requires proper cleaning, sterilization, and maintenance between procedures. No additional regulatory status beyond the stated 510(k) clearance is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980599 | Date15 Apr 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from N-Tech Endoscopy, Inc.
Questions
What is the Ntech Arthroscope used for?
The Ntech Arthroscope is designed for diagnostic and surgical visualization within joints. It allows clinicians to inspect internal joint structures—such as those in the knee, shoulder, or wrist—via a minimally invasive approach. By transmitting real-time images to an external monitor, it helps diagnose and treat musculoskeletal issues like ligament tears, cartilage damage, or degenerative joint diseases. Its precise articulation and compact design enable access to smaller joint spaces, reducing tissue trauma compared to traditional open surgery.
Is the Ntech Arthroscope single-use or reusable?
The Ntech Arthroscope is explicitly supplied as a reusable medical device. It is intended for repeated use in sterile operating room environments, provided it undergoes proper cleaning, sterilization, and maintenance between procedures. Reusability is supported by its durable construction and compliance with FDA 510(k) clearance for reusable arthroscopic devices, ensuring safety and reliability across multiple applications.
How should the Ntech Arthroscope be stored?
The device must be stored in a clean, dry environment protected from physical damage or contamination. Since it is reusable, storage should follow manufacturer guidelines for arthroscopic instruments, including proper packaging (e.g., sterile wraps or sealed cases) when not in use. Avoid exposure to extreme temperatures, moisture, or direct sunlight, as these can compromise sterility or material integrity. Always refer to the included maintenance manual for specific storage protocols.
What regulatory pathway does the Ntech Arthroscope follow?
The Ntech Arthroscope is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K980599. It was classified under the Gastroenterology and Urology advisory committees (product code GCJ) and determined to be substantially equivalent to a predicate device. This pathway confirms its compliance with U.S. safety and performance standards for reusable arthroscopic devices, though no additional regulatory status beyond the stated clearance is implied.
Can the Ntech Arthroscope be used for all joint types?
The device’s design supports visualization and manipulation in smaller joint spaces, including the knee, shoulder, and wrist. However, its suitability for specific joints depends on clinical judgment and procedural requirements. Larger joints (e.g., hip) may require alternative arthroscopic tools due to anatomical constraints. Always consult the device’s technical specifications and manufacturer instructions to confirm compatibility with the intended joint and procedure.