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
361–384 of 756
Cleared Sep 15, 1995
PTFE SYRINGE FILTER
K952918
B.Braun Medical, Inc.
General Hospital · 81d
Cleared Aug 25, 1995
STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS
K950824
Stryker Corp.
General Hospital · 183d
Cleared Jul 20, 1995
SURGICAL TECHNOLOGIES, INC. SYRINGE
K951918
Surgical Technologies, Inc.
General Hospital · 87d
Cleared Mar 17, 1995
DRUG DISPENSING SPIKE
K946190
Gelman Sciences, Inc.
General Hospital · 87d
Cleared Mar 01, 1995
MONOJECT(R) PISTON SYRINGES
K945715
Sherwood Medical Co.
General Hospital · 100d
Cleared Feb 10, 1995
DISPOSABLE 1CC SYRINGE WITH LUER LOCK
K945588
Interventional Therapeutics Corp.
General Hospital · 88d
Cleared Sep 06, 1994
SYRINGE FILTER DEVICES
K941589
Gelman Sciences, Inc.
General Hospital · 159d
Cleared Aug 10, 1994
DRUG RECONSTITUTION FILTER DEVICE
K941020
Gelman Sciences, Inc.
General Hospital · 160d
Cleared Aug 05, 1994
IRRIGATION TRAY WITH PISTON SYRINGE
K942221
Trinity Laboratories, Inc.
General Hospital · 91d
Cleared Jul 21, 1994
SYRINGE
K942615
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 49d
Cleared Jun 17, 1994
MEDSAVER SYRINGE
K941095
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 100d
Cleared Jun 10, 1994
CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
K935092
Contour Fabricators of Florida, Inc.
General Hospital · 228d
Cleared May 27, 1994
UNKNOWN
K941032
Gelman Sciences, Inc.
General Hospital · 81d
Cleared May 26, 1994
1ML LUER-LOK SYRINGE
K941562
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 55d
Cleared May 26, 1994
BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE
K941657
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 51d
Cleared May 23, 1994
ADVANTAGE SYRINGE
K941545
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 54d
Cleared Mar 01, 1994
RIVER VIAL ADAPTER
K933335
River Medical, Inc.
General Hospital · 236d
Cleared Feb 10, 1994
ONE TIME VIAL ACCESS SPIKE
K934561
Icu Medical, Inc.
General Hospital · 142d
Cleared Sep 16, 1993
SPRING LOADED SYRINGE
K931095
Acacia, Inc.
General Hospital · 197d
Cleared Jul 29, 1993
MONOJECT(R) 6 CC SAFETY SYRINGE
K924511
Sherwood Medical Co.
General Hospital · 328d
Cleared Jul 13, 1993
FIBRACOL COLLAGEN-ALGINATE DRESSING
K925548
Johnson & Johnson Medical, Inc.
General Hospital · 252d
Cleared Jul 12, 1993
ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY
K930847
Sherwood Medical Co.
General Hospital · 144d
Cleared May 17, 1993
BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.
K930321
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 115d
Cleared Apr 07, 1993
BECTON DICKINSON ARTERIAL BLOOD GAS KITS
K930342
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 72d