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
409–432 of 756
Cleared Aug 23, 1988
BD MICROFINE IV PEN INJECTOR
K881775
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 119d
Cleared Aug 10, 1988
MX350 (SERIES) CONTROL SYRINGE
K883094
Medex, Inc.
General Hospital · 19d
Cleared Jun 24, 1988
HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON.
K880963
Buckman Co., Inc.
General Hospital · 108d
Cleared Jun 16, 1988
DISPOSABLE SYRINGE
K882335
Baxter Healthcare Corp
General Hospital · 10d
Cleared May 11, 1988
MEDSURG MYELOGRAM TRAY
K880693
Medsurg Industries, Inc.
General Hospital · 79d
Cleared Mar 31, 1988
ALLERGIST SYRINGES
K880894
Abco Dealers, Inc.
General Hospital · 29d
Cleared Sep 04, 1987
JMS NEEDLES AND JMS SYRINGES
K871965
Jms Co., Ltd.
General Hospital · 108d
Cleared Sep 04, 1987
SAFETY SYRINGE
K872820
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 50d
Cleared Sep 04, 1987
LOOK SPRING-ASSIST SYRINGES
K872944
Look, Inc.
General Hospital · 38d
Cleared Aug 06, 1987
MONOJECT PHARMACY TRAY
K860688
Sherwood Medical Co.
General Hospital · 527d
Cleared Apr 29, 1987
SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT
K870518
Surgitek
General Hospital · 83d
Cleared Mar 17, 1987
ACCUPEN(R)
K870078
Ulster Scientific, Inc.
General Hospital · 68d
Cleared Jan 20, 1987
REFILLABLE SYRINGE
K864407
Med Fusion Systems, Inc.
General Hospital · 71d
Cleared Dec 29, 1986
VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES
K864747
Jms Co., Ltd.
General Hospital · 24d
Cleared Dec 16, 1986
USI AUTOJECT INSULIN SYRINGE
K864761
Ulster Scientific, Inc.
General Hospital · 11d
Cleared Dec 01, 1986
3 RING ATTACHMENT
K864555
Professional Medical Services
General Hospital · 12d
Cleared Apr 23, 1986
DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES
K861153
Exel Intl.
General Hospital · 28d
Cleared Dec 05, 1985
ADDITIVE EXTENSION SYRINGE
K853120
Abbott Laboratories
General Hospital · 133d
Cleared Nov 12, 1985
SPAN / AID SYRINGE
K854255
Span-America Medical Systems, Inc.
General Hospital · 21d
Cleared Oct 16, 1985
JMS LCC INSULIN SYRINGE
K853838
Jms Co., Ltd.
General Hospital · 72d
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