Skip to content

Top Hypodermic Syringe Piston

by Top Surgical Manufacturers Co.

510(k) K843414

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 NumberK843414 Date7 Sep 1984ClearedStatusActive

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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
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 Top Hypodermic Syringe Piston is a syringe, piston device consisting of a calibrated hollow barrel and a movable plunger, used to inject fluids into, or withdraw fluids from, the body. It has a male connector for fitting the female connector of a hypodermic single lumen needle.

The device is supplied with a product code of FMF and is classified as a class 2 device. It is used in a general hospital setting and has an FDA 510K clearance with the number K843414. The device is substantially equivalent and was cleared on September 7, 1984.

Other devices from Top Surgical Manufacturers Co.

See all devices from Top Surgical Manufacturers Co. →

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 Top Hypodermic Syringe Piston used for?

    This device is used to inject fluids into or withdraw fluids from the body. It consists of a calibrated hollow barrel and a movable plunger, designed to fit a hypodermic single lumen needle via its male connector.

  • How is the device supplied and what is its product code?

    The device is supplied under the product code FMF. It is classified as a class 2 medical device and is intended for use in a general hospital setting.

  • Is the Top Hypodermic Syringe Piston sterile and single-use?

    The device data does not specify sterility or single-use status. Users should refer to the manufacturer's labeling or contact Top Surgical Manufacturers Co. for details on sterilization method and reuse instructions.

  • What sizes and models are available?

    The provided specifications do not list available sizes or models. For specific configurations, volumes, or barrel sizes, consult the manufacturer directly or request the product catalog.

  • How should the device be stored?

    Storage requirements are not detailed in the device data. It is recommended to store the syringe in a dry, clean environment away from direct sunlight and extreme temperatures, following standard medical device handling protocols.