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
289–312 of 756
Cleared Feb 13, 2002
HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
K014073
Portex, Inc.
General Hospital · 65d
Cleared Oct 29, 2001
MICROMEDICS FIBRIJET AEROSOL APPLICATOR
K012868
Micromedics, Inc.
General Hospital · 63d
Cleared Sep 19, 2001
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087
Orthovita, Inc.
General Hospital · 162d
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 Dec 29, 2000
INJECTRITE-C15 AND INJECTRITE-C30
K002127
Sterling Medivations, Inc.
General Hospital · 168d
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 Jun 06, 2000
THE WAND
K992404
Spintech, Inc.
General Hospital · 323d
Cleared Apr 25, 2000
HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01
K994023
Haemacure Corp.
General Hospital · 151d
Cleared Mar 24, 2000
ULTICARE DISPOSABLE SYRINGE
K994230
Ultimed, Inc.
General Hospital · 99d
Cleared Feb 25, 2000
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
K993017
Shinchang Medical Co., Ltd.
General Hospital · 170d
Cleared Feb 14, 2000
VEIN ENTRY INDICATOR DEVICE (VEID)
K993995
Vascular Technologies , Ltd.
General Hospital · 82d
Cleared Feb 11, 2000
NIPRO INSULIN SYRINGE
K000144
Nipro Medical Corp.
General Hospital · 24d
Cleared Jan 05, 2000
VACLOK SYRINGE
K994253
Merit Medical Systems, Inc.
General Hospital · 19d
Cleared Nov 22, 1999
DISETRONIC PEN P100
K993666
Disetronic Medical Systems
General Hospital · 21d
Cleared Oct 08, 1999
SEALOUETTE FIBRIN SEALANT APPLICATOR
K992351
Biosurgical Corp.
General Hospital · 86d
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 24, 1999
TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
K990020
Te ME NA S.A.R.L.
General Hospital · 171d
Cleared Jun 14, 1999
MONOJECT INSULIN SYRINGE
K991758
The Kendal Co.
General Hospital · 21d
Cleared May 21, 1999
EASYSAFE RETRACTING NEEDLE SYRINGE
K991039
Saf-T-Med, Inc.
General Hospital · 53d