Eclipse 3200 For Use In Urology Applications
by Cardiogenes
510(k) K931305
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK931305 | Date7 Jan 1994 | 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- Withdrawn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, 22 Sep 2026
The Eclipse 3200 is a device for use in urology applications. It is a Class 2 General & Plastic Surgery device with product code GEX. The device was cleared through the Traditional 510(k) pathway after a 227-day FDA review.
The Eclipse 3200 is manufactured by Cardiogenes and received FDA 510(k) clearance on January 7, 1994. The device is intended for use in urology applications and is supplied with model number K931305. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage is provided in the device data.
Other devices from Cardiogenes
Questions
AI-generated answers, 22 Sep 2026
What is the Eclipse 3200 device used for?
The Eclipse 3200 is specifically designed for use in urology applications. It is a Class 2 General & Plastic Surgery device with product code GEX, manufactured by Cardiogenes.
What is the regulatory status of the Eclipse 3200?
The Eclipse 3200 received FDA 510(k) clearance on January 7, 1994, through the Traditional pathway after a 227-day FDA review. It was determined to be substantially equivalent to predicate devices.
What model number and manufacturer information is available for the Eclipse 3200?
The Eclipse 3200 is supplied with model number K931305 and is manufactured by Cardiogenes, located in Palo Alto, California. The company's contact person is Murphy-Chutorian.
Is the Eclipse 3200 sterile or single-use?
The device data does not provide information regarding sterility status, whether the device is single-use or reusable, MRI safety, available sizes, or storage requirements.