Monoject 6 CC Safety Syringe

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

Full name

Monoject(R) 6 Cc Safety Syringe

510(k) Number

K924511 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Argyle Vac-U-Care 100cc Suct. Reservoir

  Class I

  FDA 510(k) K801372 Active Cleared 26 Jun 1980

• Argyle Aspr-Care Closed Suction System

  Class I

  FDA 510(k) K934723 Active Cleared 30 Nov 1993

• Labcer Fibrinogen Assay Kit & Calibr.

  Class II

  FDA 510(k) K812570 Active Cleared 2 Oct 1981

• Monoject(R) Trace Element Blood Collection Tube

  Class II

  FDA 510(k) K883320 Active Cleared 27 Sep 1988

• Monoject Samplette Amber Capillary Serum Separator

  Class I

  FDA 510(k) K875061 Active Cleared 12 Jan 1988

• Argyle Turkel Safety Trocar Thoracic Catheter

  Class I

  FDA 510(k) K933510 Active Cleared 24 Feb 1994

See all devices from Sherwood Medical Co. →

• What is the Monoject 6 CC Safety Syringe used for?

  The Monoject 6 CC Safety Syringe is designed for the safe administration of medications or fluids. It incorporates safety features specifically engineered to help prevent needlestick injuries during medical procedures.

• Is the Monoject 6 CC Safety Syringe reusable or single-use?

  This syringe is supplied sterile and is intended for single-use only. After use, it should be properly disposed of according to medical waste protocols to ensure safety and prevent reuse.

• What regulatory approval does the Monoject 6 CC Safety Syringe have?

  The Monoject 6 CC Safety Syringe received FDA 510(k) clearance with number K924511 on July 29, 1993. It was classified as substantially equivalent under product code FMF by the General Hospital advisory committee.

• Who manufactures the Monoject 6 CC Safety Syringe?

  The Monoject 6 CC Safety Syringe is manufactured by Sherwood Medical Co., located at 1915 Olive St., St. Louis, MO 63103. The company has been producing this safety syringe since it received FDA clearance in 1993.