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Grieshaber Viscoelastic Injection System

by Grieshaber & Co.

510(k) K890783

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890783 Date16 May 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.