Monoject Sterile M506 6CC Syringes

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

510(k) Number

K812023 ↗

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 M506 6cc syringe designed for?

  The Monoject M506 6cc syringe is designed for precise liquid administration in clinical settings, such as intravenous or subcutaneous injections. Its piston-type mechanism ensures consistent delivery of medication or fluids, making it suitable for general hospital use where accuracy and reliability are critical.

• Are these syringes reusable or intended for single-use?

  These syringes are explicitly intended for single-use only. The design and sterility classification align with standard infection control practices to prevent cross-contamination, ensuring patient safety and compliance with medical protocols.

• What capacity does the M506 model offer, and are there variations?

  The M506 model is available exclusively in a 6 cubic centimeter (cc) capacity. There are no additional variations or sizes specified for this particular model, making it a straightforward choice for standard dosing requirements.

• How should these syringes be stored to maintain their integrity?

  To maintain sterility and functionality, these syringes should be stored according to the manufacturer’s guidelines. This typically involves keeping them in a clean, dry environment, protected from direct light and extreme temperatures, and ensuring the packaging remains intact until use.

• What regulatory pathway does this device follow?

  The Monoject M506 6cc syringe follows the FDA’s 510(k) clearance pathway, granted in 1981 under the product code FMF (Syringe, Piston). It was classified as substantially equivalent to a predicate device and falls under FDA’s Class II – Special Controls, ensuring it meets established safety and performance standards.