Hypodermic Syringe

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K771205 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Urogard Urinary Drainage Bag

  Class II

  FDA 510(k) K771210 Active Cleared 11 Jul 1977

• Terumo Imugard

  Class II

  FDA 510(k) K790105 Active Cleared 24 May 1979

• Blood Filter, W/Set

  Class II

  FDA 510(k) K771430 Active Cleared 20 Sep 1977

• Av Fistula Needle Set

  Class II

  FDA 510(k) K771206 Active Cleared 15 Jul 1977

• Terufusion Blood Admin. Set

  Class II

  FDA 510(k) K771209 Active Cleared 26 Jul 1977

• Hicaliq Ivh Bag

  Class II

  FDA 510(k) K771432 Active Cleared 28 Sep 1977

See all devices from Terumo America, Inc. →

• Is this syringe reusable, or is it meant for single-use only?

  This hypodermic syringe is explicitly designed for single-use only and must not be reused or reprocessed. The manufacturer emphasizes this in the packaging as a tamper-evident blister pack, ensuring sterility and safety for one-time administration of medications or vaccines.

• What types of liquids can this syringe be used to administer, and how do I verify the dosage?

  The syringe is intended for the precise administration of liquids, including medications and vaccines, via parenteral routes (e.g., injections). The ultra-clear plastic barrel features bold scale markings, allowing users to easily verify the dosage before administration. The double-bevel needle design further supports accuracy and user comfort.

• How is this syringe packaged, and what should I check before use?

  The syringe comes in tamper-evident blister packs, which help maintain sterility and integrity. Before use, you should verify that the packaging is intact and unopened—any signs of tampering or damage indicate the device should not be used. Additionally, check the scale markings for clarity and ensure the needle (if included) is securely attached.

• Are there different sizes or models available, and how do I identify them?

  While the provided data does not specify exact sizes or models, hypodermic syringes like this typically come in various barrel volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, etc.). The scale markings on the barrel indicate the volume, and the presence or absence of a needle (single-use or needleless) may differentiate models. Always confirm the correct size for your intended use before administration.

• What regulatory pathway does this device follow, and where is it distributed?

  This syringe holds FDA 510(k) clearance (K771205) under the product code FMF, classified as substantially equivalent to predicate devices. It is manufactured by Terumo America, Inc. and distributed in the U.S. and Canada, adhering to regulatory standards for single-use medical devices. The clearance was granted under the General Hospital (HO) advisory committee in 1977.