Sterilized Omni Gel
510(k) K872519
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872519 | Date3 Aug 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JOT
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Sterilized Omni Gel is an electrosurgical gel electrode, substantially equivalent to other devices. It is classified as a class 2 device. The device is used in general and plastic surgery applications.
The Sterilized Omni Gel is supplied sterile and has FDA 510(k) authorization, with clearance type traditional and regulation number 878.4400. The device has a product code of JOT and is manufactured by Echo Ultrasound.
Other devices from Echo Ultrasound
Questions
AI-generated answers, 1 Oct 2026
What is the Sterilized Omni Gel used for?
The Sterilized Omni Gel is used in general and plastic surgery applications as an electrosurgical gel electrode.
Is the Sterilized Omni Gel supplied sterile?
Yes, the Sterilized Omni Gel is supplied sterile, ensuring a clean and safe application in surgical procedures.
What type of authorization does the Sterilized Omni Gel have?
The Sterilized Omni Gel has FDA 510(k) authorization with a traditional clearance type and regulation number 878.4400.