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
193–216 of 753
Cleared Jul 15, 1998
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 359d
Cleared Jun 25, 1998
BECTON DICKINSON SYRINGES
K980580
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 128d
Cleared Jun 12, 1998
B-D PEN ULTRA
K981797
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 22d
Cleared Jun 11, 1998
BECTON DICKINSON SYRINGE
K980987
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 86d
Cleared Apr 02, 1998
TERUMO DISPOSABLE HYPODERMC SYRINGE
K980181
Terumo Medical Corp.
General Hospital · 72d
Cleared Apr 02, 1998
B-D E ML PEN
K980755
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 36d
Cleared May 21, 1996
TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
K953940
Terumo Medical Corp.
General Hospital · 274d
Cleared Nov 21, 1995
BECTON DICKINSON SYRINGSE
K954064
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 83d
Cleared Nov 13, 1995
GENOTROPIN MIXER
K954337
Pharmacia, Inc.
General Hospital · 56d
Cleared Oct 24, 1995
B-D PEN ULTRA
K951919
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 183d
Cleared Oct 19, 1995
PISTON SYRINGE
K951025
Pharmacia, Inc.
General Hospital · 227d
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 Mar 01, 1995
MONOJECT(R) PISTON SYRINGES
K945715
Sherwood Medical Co.
General Hospital · 100d
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 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 Feb 10, 1994
ONE TIME VIAL ACCESS SPIKE
K934561
Icu Medical, Inc.
General Hospital · 142d
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