Skip to content

Syringe Driver MS-16

by Intermedics, Inc. 510(k)

Active United States

510(k) K830423

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830423 Date7 Mar 1983ClearedStatusActive

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  • Withdrawn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
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Syringe Driver MS-16 is a pump, infusion device designed to deliver controlled volumes of fluids from a syringe at a precise rate. It is classified as a Class II medical device and operates by mechanically driving the plunger of a syringe to administer medications, nutrients, or other fluids in a consistent and programmable manner. This device is intended for use in general hospital settings, where precise fluid delivery is required for patient care.

The Syringe Driver MS-16 is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K830423) with a decision of Substantially Equivalent to a predicate device. It is intended for use in controlled environments such as hospitals and is not classified as single-use. The device is manufactured by Intermedics, Inc. (Mchenry, IL, US) and falls under the product code FRN, adhering to FDA regulation 880.5725. No specific MRI safety or sterility requirements are noted in the available data.

Other devices from Intermedics, Inc.

See all devices from Intermedics, Inc. →