Grieshaber Viscoelastic Injection System
510(k) K890783
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK890783 | Date16 May 1989 | 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- Withdrawn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
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Grieshaber Viscoelastic Injection System is an infusion pump designed for the controlled delivery of viscous substances. It functions as a medical device to facilitate the precise administration of these materials during clinical procedures.
This system is supplied with components including a footswitch and a manual. It is regulated under FDA 510(k) clearance K890783 and is classified as a class 2 device.
Other devices from Grieshaber & Co.
Questions
AI-generated answers, 23 Sep 2026
What is the primary function of the Grieshaber Viscoelastic Injection System?
This device is an infusion pump engineered to provide controlled delivery of viscous substances, allowing for the precise administration of these materials during clinical procedures.
What components are included with the system?
The system is supplied with the infusion pump unit, a footswitch for operation, and a manual to assist with setup and usage.
How is this device regulated?
The Grieshaber Viscoelastic Injection System is a class 2 medical device regulated under FDA 510(k) clearance number K890783.