Monoject Tray Size Sharps Container

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

510(k) Number

K943496 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

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

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  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 Tray Size Sharps Container used for?

  It is designed for the safe disposal of medical sharps such as used needles, syringes, and other sharp instruments in healthcare settings. Its tray size allows for convenient placement on work surfaces during procedures.

• Is the Monoject Tray Size Sharps Container sterile or non-sterile, and is it reusable?

  The container is supplied non-sterile and is intended for single-use only. It should not be reprocessed or reused after initial use to maintain safety and integrity for sharps containment.

• What regulatory clearance does the Monoject Tray Size Sharps Container have?

  The device received FDA 510(k) clearance under submission K943496 on August 29, 1994. It was found substantially equivalent to a predicate device and is classified under product code FMI for general hospital use.