FMF · Class II · 21 CFR 880.5860

FDA Product Code FMF: Syringe, Piston

Under FDA product code FMF, piston syringes are cleared for the aspiration and injection of fluids in clinical settings.

These devices consist of a cylindrical barrel and a sliding plunger that creates suction or pressure to draw in or expel liquids. They are used for medication injection, wound irrigation, aspiration of body fluids, and enteral feeding across all care settings.

FMF devices are Class II medical devices, regulated under 21 CFR 880.5860 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Sherwood Medical Co. and Becton, Dickinson and Company.

756
Total
756
Cleared
124d
Avg days
1976
Since
756 devices
217–240 of 756
Cleared May 13, 2011
BD SINGLE USE, HYPODERMIC SYRINGE
K110771
Becton, Dickinson and Company
General Hospital · 53d
Cleared Apr 26, 2011
DISPOSABLE INSULIN SYRINGE
K110421
Wenzhou Wuzhou Import & Export Co., Ltd.
General Hospital · 71d
Cleared Apr 20, 2011
CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE
K110112
Rongshan LI
General Hospital · 96d
Cleared Apr 12, 2011
PROPEP DELIVERY DEVICE
K103200
Rhythmlink International, LLC
General Hospital · 162d
Cleared Feb 23, 2011
INDISCAL DIGITAL MANOMETER
K102192
Baylis Medical Co., Inc.
General Hospital · 203d
Cleared Jun 09, 2010
GRAFT DELIVERY SYSTEM MODEL SA-6115
K100754
Micromedics, Inc.
General Hospital · 84d
Cleared May 10, 2010
EPIDRUM
K093863
Exmoor Plastics , Ltd.
General Hospital · 144d
Cleared Mar 12, 2010
COAXIAL APPLICATOR SYSTEM
K091722
Biomet, Inc.
General Hospital · 274d
Cleared Oct 27, 2009
ACACIA PISTON SYRINGE
K092986
Acacia, Inc.
General Hospital · 29d
Cleared Aug 12, 2009
NIPRO DISPOSABLE SYRINGE
K091279
Nipro Medical Corporation
General Hospital · 103d
Cleared Jul 02, 2009
BD FLU+ SYRINGE
K091377
Becton, Dickinson & CO
General Hospital · 52d
Cleared May 22, 2009
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K083514
Terumo Europe N.V.
General Hospital · 177d
Cleared Nov 07, 2008
MICROMYST APPLICATOR, MODEL 20-5000
K082454
Covidien
General Hospital · 73d
Cleared May 02, 2008
UNIVERSAL VIAL ACCESS SPIKE
K080989
Icu Medical, Inc.
General Hospital · 25d
Cleared Dec 06, 2007
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330
Biomet, Inc.
General Hospital · 108d
Cleared Oct 05, 2007
ICU MEDICAL SINGLE-USE SYRINGE
K070856
Icu Medical, Inc.
General Hospital · 191d
Cleared Aug 23, 2007
SMALL VOLUME SYRINGE
K062865
Alcon Laboratories
General Hospital · 332d
Cleared Aug 16, 2007
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459
B.Braun Medical, Inc.
General Hospital · 83d
Cleared Jul 11, 2007
TERUMO 31G THINPRO INSULIN SYRINGE
K071630
Terumo Medical Corp.
General Hospital · 27d
Cleared Jun 05, 2007
GENIE, MODEL CH-200
K070633
Icu Medical, Inc.
General Hospital · 90d
Cleared May 29, 2007
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
K070264
Terumo Europe N.V.
General Hospital · 120d
Cleared Feb 26, 2007
CAPTION APPLICATOR
K063535
Smith & Nephew, Inc.
General Hospital · 96d
Cleared Jan 26, 2007
AUTO-FILL SYRINGE KIT, MODEL 7600
K063851
Vascular Solutions, Inc.
General Hospital · 29d
Cleared Dec 26, 2006
MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE
K063613
Terumo Medical Corp.
General Hospital · 21d