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.

753
Total
753
Cleared
124d
Avg days
1976
Since
753 devices
169–192 of 753
Cleared Aug 16, 2005
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034
Terumo Medical Corp.
General Hospital · 19d
Cleared Jul 25, 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720
Synthes (Usa)
General Hospital · 28d
Cleared May 18, 2005
STRYKER DISCMONITOR
K050753
Stryker Instruments
General Hospital · 56d
Cleared Oct 28, 2004
1BD SOLOSHOT IX SYRINGE
K042934
Becton, Dickinson & CO
General Hospital · 3d
Cleared Aug 23, 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976
Smith & Nephew, Inc.
General Hospital · 32d
Cleared Feb 13, 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721
Vascular Solutions, Inc.
General Hospital · 79d
Cleared Feb 21, 2003
MERIT MEDICAL 1-ML SYRINGE
K024052
Merit Medical Systems, Inc.
General Hospital · 77d
Cleared Jan 09, 2003
BD INSULIN SYRINGE
K024112
Becton, Dickinson & CO
General Hospital · 27d
Cleared Dec 18, 2002
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K023271
Terumo Medical Corp.
General Hospital · 78d
Cleared Oct 02, 2002
BONE GRAFT SYRINGE, MODEL 8600-00X0
K023088
Wrightmedicaltechnologyinc
General Hospital · 15d
Cleared Aug 02, 2002
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K022246
Depuyacromed
General Hospital · 21d
Cleared Jul 01, 2002
PCCS GRAFT DELIVERY SYSTEM
K021071
Biomet, Inc.
General Hospital · 90d
Cleared Jun 24, 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666
Baxter Healthcare Corp
General Hospital · 115d
Cleared Jun 07, 2002
DUPLOREACH
K014088
Baxter Healthcare Corp
General Hospital · 177d
Cleared Apr 30, 2001
APPLICATOR TIP/DUAL SPRAYER KIT
K010708
Interpore Cross Intl.
General Hospital · 52d
Cleared Feb 12, 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571
Terumo Medical Corp.
General Hospital · 84d
Cleared Jan 08, 2001
STERILE PISTON SYRINGE
K002717
Abbott Laboratories
General Hospital · 130d
Cleared Nov 07, 2000
DUPLOGRIP
K003193
Baxter Healthcare Corp
General Hospital · 26d
Cleared Jul 05, 2000
TISSOMAT AND SPRAY SET
K981089
Baxter Healthcare Corp
General Hospital · 833d
Cleared Jun 09, 2000
TERUMO U-100 INSULIN SYRING
K001474
Terumo Medical Corp.
General Hospital · 29d
Cleared Jan 05, 2000
VACLOK SYRINGE
K994253
Merit Medical Systems, Inc.
General Hospital · 19d
Cleared Sep 09, 1999
TERUMO U-100 INSULIN SYRINGE
K992802
Terumo Medical Corp.
General Hospital · 21d
Cleared Jul 08, 1999
MTI 1 ML SYRINGE
K991225
Micro Therapeutics, Inc.
General Hospital · 87d
Cleared Jun 14, 1999
MONOJECT INSULIN SYRINGE
K991758
The Kendal Co.
General Hospital · 21d