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
241–264 of 753
Cleared Dec 05, 1985
ADDITIVE EXTENSION SYRINGE
K853120
Abbott Laboratories
General Hospital · 133d
Cleared Jul 23, 1985
MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
K852544
Sherwood Medical Co.
General Hospital · 39d
Cleared Jul 23, 1985
MONOJECT STERILE 60CC SYRINGES
K852580
Sherwood Medical Co.
General Hospital · 35d
Cleared Jul 23, 1985
MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES
K852588
Sherwood Medical Co.
General Hospital · 35d
Cleared Jul 23, 1985
MONJECT STERILE 20CC SYRINGES
K852607
Sherwood Medical Co.
General Hospital · 34d
Cleared Jul 23, 1985
MONOJECT STERILE 35CC SYRINGES
K852640
Sherwood Medical Co.
General Hospital · 33d
Cleared Apr 12, 1985
MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES
K851089
Sherwood Medical Co.
General Hospital · 25d
Cleared Apr 12, 1985
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090
Sherwood Medical Co.
General Hospital · 25d
Cleared Apr 10, 1985
BLOOD GAS SAMPLER KIT
K850958
Churchill Corp.
General Hospital · 33d
Cleared Jan 14, 1985
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106
Abco Dealers, Inc.
General Hospital · 83d
Cleared Apr 17, 1984
FLUID REMOVAL ASSEMBLY
K840490
Ackrad Laboratories
General Hospital · 71d
Cleared Mar 06, 1984
HYPODERMIC SYRINGES & NEEDLES
K834548
Cordis Corp.
General Hospital · 70d
Cleared Jan 10, 1984
SYRINGE
K833399
I M, Inc.
General Hospital · 97d
Cleared Dec 12, 1983
MULTI PURPOSE SYRINGE
K833435
I M, Inc.
General Hospital · 68d
Cleared Oct 04, 1983
DIRECTOR
K832658
Pharmacia, Inc.
General Hospital · 57d
Cleared Nov 03, 1982
ANGIOUROGRAPHY KIT
K822159
Mallinckrodt Critical Care
General Hospital · 103d
Cleared Nov 03, 1982
9110 SYRINGE
K822774
Cardiac Pacemakers, Inc.
General Hospital · 50d
Cleared Oct 18, 1982
LARYNGEAL SYRINGE
K822185
Kelleher Corp.
General Hospital · 87d
Cleared Aug 16, 1982
U-100 INSULIN SYRINGE
K822083
Terumo Medical Corp.
General Hospital · 35d
Cleared Jul 28, 1982
MONOJET 520 20CC SYRINGES W/NEEDLES
K822029
Sherwood Medical Co.
General Hospital · 16d
Cleared Apr 14, 1982
MONOJECT 512 SYRINGES W/WO NEEDLES
K820716
Sherwood Medical Co.
General Hospital · 30d
Cleared Mar 08, 1982
THE RED CAP
K820454
Burron Medical Products, Inc.
General Hospital · 18d
Cleared Jan 05, 1982
MONOJECT M560 60CC SYRINGES
K813480
Sherwood Medical Co.
General Hospital · 35d
Cleared Nov 27, 1981
20CC GLASS CONTROL SYRINGE
K813175
Abco Dealers, Inc.
General Hospital · 18d