Identifiers
- 510(k) Number
- K991656 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 device used for visualizing, diagnosing, and treating conditions within a joint. The AED Arthroscope is an orthopedic endoscopic instrument designed for use in arthroscopic procedures.
It is supplied as a reusable device intended for use in clinical settings such as operating rooms or outpatient surgical centers. The device received FDA 510(k) clearance (K991656) as substantially equivalent to a legally marketed predicate device, with review by the Orthopedic advisory committee.
Frequently asked questions
What is the AED Arthroscope used for?
The AED Arthroscope is an orthopedic endoscopic instrument designed for use in arthroscopic procedures to visualize, diagnose, and treat conditions within a joint, as stated in its device description.
Is the AED Arthroscope reusable or single-use?
The AED Arthroscope is supplied as a reusable device intended for use in clinical settings such as operating rooms or outpatient surgical centers, according to the provided device data.
What regulatory pathway was used for the AED Arthroscope?
The AED Arthroscope received FDA 510(k) clearance (K991656) as substantially equivalent to a legally marketed predicate device, with review by the Orthopedic advisory committee.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991656 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA 510(k) K991656 24 fields · synced Sep 23, 2026