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10CC Control Syringe

by Medi-Plast Intl., Inc.

510(k) K873588

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 NumberK873588 Date23 Oct 1987ClearedStatusActive

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  • Withdrawn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, 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 10CC Control Syringe is a syringe, plastic (per FDA product code FMF) designed for precise fluid administration and aspiration in clinical settings. Its controlled plunger mechanism ensures accurate dosing, making it suitable for intravenous injections, medication delivery, or sample collection. Constructed from medical-grade plastic, it adheres to standards for single-use disposable devices, ensuring sterility and patient safety. The device’s design minimizes dead space, enhancing reliability for critical procedures.

This syringe is supplied as a single-use, sterile device and is intended for use in General Hospital settings, as classified under FDA’s advisory committee review. It is not reusable and must be discarded after one use to maintain sterility. The 10CC capacity is standardized for common clinical applications, and storage should follow manufacturer guidelines to preserve integrity. Authorized under FDA 510(k) clearance (K873588), it complies with regulatory requirements for Class II medical devices.

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Questions

AI-generated answers, 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.

  • What is the 10CC Control Syringe designed for?

    The 10CC Control Syringe is engineered for precise fluid administration and aspiration in clinical settings. Its controlled plunger mechanism ensures accurate dosing, making it ideal for intravenous injections, medication delivery, or sample collection where exact volumes are critical.

  • Is the 10CC Control Syringe reusable or single-use?

    This syringe is explicitly designed for single-use only. It is classified as a disposable medical device to maintain sterility and patient safety, requiring disposal after one use to prevent contamination or cross-infection.

  • What material is the 10CC Control Syringe made from?

    The syringe is constructed from medical-grade plastic, adhering to standards for single-use disposable devices. This material ensures durability, sterility, and compatibility with common clinical fluids while minimizing dead space for improved accuracy.

  • How should the 10CC Control Syringe be stored?

    Storage should follow the manufacturer’s guidelines to preserve the syringe’s integrity. Typically, this involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened until use to maintain sterility.

  • What capacity does the 10CC Control Syringe have, and is it standardized?

    The syringe has a standardized capacity of 10 cubic centimeters (cc), which is commonly used in clinical settings for tasks requiring precise volume control. This fixed capacity aligns with typical dosing needs for intravenous injections and sample collection procedures.