Opticon Connector Adapter II
by Xintec Corporation 510(k)
Active
510(k) K942759
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942759 | Date31 Aug 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Opticon(Tm) Connector Adapter II
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Opticon Connector Adapter II is a device used for connecting and adapting components in medical procedures. It is designed to facilitate secure connections between medical devices or systems.
The device is supplied by Xintec Corporation and is authorized under FDA 510K clearance with product code GEX. It is available in various sizes and is intended for use in general and plastic surgery settings.
Other devices from Xintec Corporation
Questions
AI-generated answers, 21 Sep 2026
What is the Opticon Connector Adapter II used for?
The Opticon Connector Adapter II is designed to facilitate secure connections between medical devices or systems, specifically intended for use in general and plastic surgery settings.
What sizes and models of the Opticon Connector Adapter II are available?
The Opticon Connector Adapter II is available in various sizes to accommodate different medical device connection requirements, though specific size dimensions are not provided in the device data.
Is the Opticon Connector Adapter II a single-use or reusable device?
The device data does not specify whether the Opticon Connector Adapter II is designed for single-use or multiple uses, so this information would need to be obtained directly from the manufacturer.
What is the regulatory status of the Opticon Connector Adapter II?
The Opticon Connector Adapter II is authorized under FDA 510K clearance with product code GEX, having received clearance on August 31, 1994, as substantially equivalent to predicate devices.