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, Becton, Dickinson and Company and Promisemed Hangzhou Meditech Co., Ltd..

750
Total
750
Cleared
124d
Avg days
1976
Since
750 devices
121–144 of 750
Cleared Apr 05, 2019
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
K182268
Flat Medical Co., Ltd.
General Hospital · 227d
Cleared Mar 14, 2019
BD Plastipak Syringe
K182589
Becton, Dickinson and Company
General Hospital · 175d
Cleared Dec 17, 2018
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
K182387
Novo Nordisk, Inc.
General Hospital · 104d
Cleared Nov 20, 2018
Orbit Subretinal Delivery System
K182274
Orbit Biomedical, Inc.
Ophthalmic · 90d
Cleared Nov 06, 2018
Merit Syringe
K182216
Merit Medical Systems, Inc.
General Hospital · 83d
Cleared Nov 06, 2018
Merit Syringe
K182279
Merit Medical Systems, Inc.
General Hospital · 76d
Cleared Oct 23, 2018
BD Single Use, Hypodermic Syringe
K172670
Becton, Dickinson and Company
General Hospital · 413d
Cleared May 10, 2018
Graftgun Universal Graft Delivery System
K180937
SurGenTec, LLC
General Hospital · 30d
Cleared Mar 30, 2018
Nipro Syringe
K173029
Nipro Medical Corporation
General Hospital · 183d
Cleared Jan 31, 2018
Merit Syringe
K173601
Merit Medical Systems, Inc.
General Hospital · 71d
Cleared Aug 07, 2017
Merit Syringe
K171362
Merit Medical Systems, Inc.
General Hospital · 90d
Cleared Aug 27, 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762
Biomet, Inc.
General Hospital · 57d
Cleared May 16, 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124
Arthrex, Inc.
General Hospital · 33d
Cleared Mar 12, 2010
COAXIAL APPLICATOR SYSTEM
K091722
Biomet, Inc.
General Hospital · 274d
Cleared Dec 06, 2007
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330
Biomet, Inc.
General Hospital · 108d
Cleared Feb 26, 2007
CAPTION APPLICATOR
K063535
Smith & Nephew, Inc.
General Hospital · 96d
Cleared Sep 29, 2006
ARTHREX ASPIRATE KIT
K062365
Arthrex, Inc.
General Hospital · 46d
Cleared Aug 23, 2006
MODIFICATION TO BONE GRAFT SYRINGE
K062173
Wrightmedicaltechnologyinc
General Hospital · 23d
Cleared Jul 19, 2006
MEDLINE SYRINGES, MULTIPLE
K061275
Medline Industries, Inc.
General Hospital · 72d
Cleared Feb 10, 2006
MODIFICATION TO: VACLOK SYRINGE
K060095
Wrightmedicaltechnologyinc
General Hospital · 28d
Cleared Jul 25, 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720
Synthes (Usa)
General Hospital · 28d
Cleared Aug 23, 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976
Smith & Nephew, Inc.
General Hospital · 32d
Cleared Oct 02, 2002
BONE GRAFT SYRINGE, MODEL 8600-00X0
K023088
Wrightmedicaltechnologyinc
General Hospital · 15d
Cleared Jul 01, 2002
PCCS GRAFT DELIVERY SYSTEM
K021071
Biomet, Inc.
General Hospital · 90d