Piston Syringe

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

510(k) Number

K811065 ↗

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 piston syringe used for?

  The piston syringe is used to draw in and expel fluids or gases in a controlled manner for medical purposes, consisting of a calibrated hollow barrel and a movable piston.

• How is the piston syringe supplied or configured?

  The device consists of a calibrated hollow barrel and a movable piston, designed for manual operation to measure and transfer specific volumes of liquids or gases during medical procedures.

• What regulatory pathway was used for the piston syringe clearance?

  The piston syringe was cleared via the Traditional 510(k) pathway under K811065, with a substantially equivalent decision dated May 5, 1981, based on the provided device data.