Monoject Sterile 35CC Syringes

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

510(k) Number

K852640 ↗

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. →

• Are these syringes reusable or meant for single-use only, and why does that matter in a clinical setting?

  These Monoject Sterile 35cc Syringes are explicitly designed for single-use only. This is critical in clinical settings because reusing syringes can introduce risks like contamination, infection, or inaccurate dosing due to wear or improper sterilization. The manufacturer’s designation as a sterile, single-use device ensures patient safety and compliance with infection control protocols.

• What types of fluids can these syringes be used for, and why is the 35cc capacity important?

  These syringes are intended for the delivery or withdrawal of fluids in general hospital settings, where precise fluid handling is required. The 35cc capacity makes them suitable for moderate-volume procedures—such as administering medications, drawing blood, or irrigating wounds—where larger volumes than standard syringes are needed but smaller than bulk containers. The capacity balances accuracy with practicality for clinical workflows.

• How should these syringes be stored, and what does the sterility guarantee mean for my facility?

  While the provided data doesn’t specify storage conditions, the syringes are sterile at the time of manufacture and packaged for single-use. Facilities should store them in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility until use. The sterility guarantee ensures they’re safe for immediate clinical use without additional sterilization, reducing preparation time and contamination risks.

• What does the FDA 510(k) clearance (K852640) mean for the reliability of these syringes in my hospital?

  The FDA 510(k) clearance (K852640) confirms these syringes were reviewed by the FDA and deemed substantially equivalent to a predicate device (a previously cleared syringe) under the General Hospital product category. This traditional clearance route indicates the manufacturer met FDA standards for safety and performance, providing assurance that the syringes meet regulatory expectations for design, materials, and clinical use in hospital environments.