Skip to content

Coeur Control Syringe

by Coeur Laboratories, Inc. 510(k)

Active United States

510(k) K874579

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874579 Date19 Jan 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Coeur Control Syringe is a medical syringe designed for precise fluid administration, classified under the product code FMF. It is intended for controlled injection procedures, ensuring accurate dosing and delivery in clinical settings.

This device is supplied as a single-use item and has received FDA 510(k) clearance under K874579, classified as substantially equivalent to a predicate device. It is intended for use in general hospital environments and is regulated under the Traditional 510(k) pathway, with no third-party review involved. No additional sterility or MRI safety information is specified in the data.

Other devices from Coeur Laboratories, Inc.

See all devices from Coeur Laboratories, Inc. →