ECLIPSE 3200
510(k) K926210
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK926210 | 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- Withdrawn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
- 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, 23 Sep 2026
The ECLIPSE 3200 is a device classified under product code GEX, which is a general, plastic surgery device. It is designed for use in medical procedures, though the specific function is not detailed in the provided data.
The ECLIPSE 3200 is manufactured by Cardiogenes and received FDA 510(k) clearance on July 28, 1993, with a K number of K926210. The device is supplied in various sizes, though specific details are not provided, and its regulatory status is that of a substantially equivalent device.
Other devices from Cardiogenes
Questions
AI-generated answers, 23 Sep 2026
What is the ECLIPSE 3200 used for?
The ECLIPSE 3200 is classified as a general plastic surgery device under product code GEX, designed for use in medical procedures, though specific functions are not detailed in the provided data.
How is the ECLIPSE 3200 supplied?
The ECLIPSE 3200 is manufactured by Cardiogenes and supplied in various sizes, though specific size details are not provided in the available information.
What is the regulatory status of the ECLIPSE 3200?
The ECLIPSE 3200 received FDA 510(k) clearance on July 28, 1993, with K number K926210, and is classified as a substantially equivalent device under product code GEX for general plastic surgery.
Is the ECLIPSE 3200 a single-use or reusable device?
The provided data does not specify whether the ECLIPSE 3200 is designed for single-use or multiple uses, as this information is not included in the device description.