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Monoject Sterile 6cc Syringe W/ & Wo/ Needles

by Sherwood Medical Co.

510(k) K852588

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 NumberK852588 Date23 Jul 1985ClearedStatusActive

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  • Withdrawn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, 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 Monoject Sterile 6cc Syringe With and Without Needles is a Syringe, Piston designed for the accurate administration, aspiration, or transfer of liquids in clinical settings. It features a 6 cubic centimetre capacity and is available with or without a preattached needle, ensuring versatility for various injection or sampling procedures. The device includes a Luer-Lock tip for secure connection to needles or other compatible accessories, enhancing usability and safety during handling.

This syringe is supplied sterile, intended for single-use only, and is latex-free. It is classified under product code FMF and was granted FDA 510(k) clearance (K852588) in 1985 under the General Hospital advisory committee. The device is intended for use in regulated medical environments, adhering to standard infection control and sterility protocols. Needles, when included, are color-coded for easy identification and come with a protective sheath.

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Questions

AI-generated answers, 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.

  • What is the Monoject 6cc syringe primarily used for in clinical settings?

    The Monoject Sterile 6cc Syringe is designed for the precise administration, aspiration, or transfer of liquids in clinical environments. Its 6 cubic centimetre capacity makes it suitable for a range of procedures, including injections, blood draws, or fluid transfers. The Luer-Lock tip ensures secure attachment to needles or other accessories, enhancing safety and usability during handling.

  • Are the needles included with this syringe reusable, and if so, how should they be handled?

    The Monoject 6cc Syringe is supplied with needles that are intended for single-use only, per standard medical practice. The needles come with a protective sheath for safe handling and are color-coded for easy identification. Reuse is not recommended to prevent contamination and ensure patient safety.

  • How should I store the Monoject 6cc Syringe to maintain its sterility?

    The Monoject 6cc Syringe is supplied sterile and must be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Keep the packaging intact until use to preserve sterility, and follow standard infection control protocols to prevent contamination.

  • What sizes or models of this syringe are available, and how do I identify them?

    This syringe is available in a single capacity: 6 cubic centimetres. It comes in two variants—with or without a preattached needle—and the included needles are color-coded for quick identification. The Luer-Lock tip is standard across all models for compatibility with additional accessories.

  • Is this syringe latex-free, and why does that matter in clinical use?

    Yes, the Monoject 6cc Syringe is explicitly labeled as latex-free, which is important for patients with latex allergies. Avoiding latex reduces the risk of allergic reactions, ensuring safer use for a broader range of patients in clinical settings.