GCB · Class I · 21 CFR 878.4200

FDA Product Code GCB: Needle, Catheter

Leading manufacturers include Medical Dynamics, Inc., B.Braun Medical, Inc. and Jelco Laboratories.

8
Total
8
Cleared
93d
Avg days
1978
Since

FDA 510(k) Cleared Needle, Catheter Devices (Product Code GCB)

8 devices
1–8 of 8
Cleared Nov 12, 2015
Valved Safety Centesis Catheter
K150800
B.Braun Medical, Inc.
General & Plastic Surgery · 231d
Cleared Jan 28, 1998
PARACENTESIS CATHETER DEVICE
K974146
Allegiance Healthcare Corp.
General & Plastic Surgery · 86d
Cleared Jul 22, 1993
ADAIR/VERESS NEEDLE INTRODUCER SET
K930568
Medical Dynamics, Inc.
General & Plastic Surgery · 177d
Cleared Aug 04, 1992
TURKEL PNEUMOTHORAX KIT
K923028
Symbiosis Corp.
General & Plastic Surgery · 42d
Cleared Apr 20, 1990
ADAIR/VERESS NEEDLE INTRODUCER SET
K900374
Medical Dynamics, Inc.
General & Plastic Surgery · 84d
Cleared Nov 13, 1985
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
K854327
Concord Laboratories, Inc.
General & Plastic Surgery · 16d
Cleared Jun 27, 1985
MANAN EPIDURAL NEEDLE
K852428
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 20d
Cleared Aug 23, 1978
NEEDLES, DESIGN CHANGE, IV CATHETERS
K780896
Jelco Laboratories
General & Plastic Surgery · 85d

About Product Code GCB - Regulatory Context