GCX · Class II · 21 CFR 880.6740

FDA Product Code GCX: Apparatus, Suction, Operating-room, Wall Vacuum Powered

Leading manufacturers include Westmark, Sterile Packing Systems, Inc. (Sps), Deknatel, Inc. and Stryker Endoscopy.

87
Total
87
Cleared
101d
Avg days
1976
Since

FDA 510(k) Cleared Apparatus, Suction, Operating-room, Wall Vacuum Powered Devices (Product Code GCX)

87 devices
1–24 of 87
Cleared Dec 09, 2004
STRYKER CASSETTE PUMP
K042454
Stryker Endoscopy
General Hospital · 90d
Cleared Aug 03, 1999
CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
K992126
Circon Corp.
General Hospital · 41d
Cleared Jul 25, 1997
SUCTION INSTRUMENTATION
K972074
Walter Lorenz Surgical, Inc.
General Hospital · 52d
Cleared Apr 17, 1997
CHASE SUCKER
K971022
Chase Medical, Inc.
General Hospital · 28d
Cleared Dec 31, 1996
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
K964127
Allegiance Healthcare Corp.
General Hospital · 77d
Cleared Dec 20, 1996
CURITY THORACENTESIS TRAY
K964519
Kendall Healthcare Products Co. Div.Of Tyco Health
General Hospital · 38d
Cleared Nov 26, 1996
STRYKER SUCTION REGULATOR
K963648
Stryker Endoscopy
General Hospital · 75d
Cleared Oct 21, 1996
RENTON SUCTION DEVICE U.S. PATENT*4,767,404
K962920
R&S Surgical, LLC
General Hospital · 87d
Cleared Jul 19, 1996
MEDCARE SUCTION CONNECTING TUBING
K961880
Medcare Medical Group, Inc.
General Hospital · 65d
Cleared Mar 28, 1996
CPR YANKAUER
K960223
Custom Pack Reliability
General Hospital · 72d
Cleared Jan 19, 1996
MEDCARE YANKAUER SUCTION DEVICE
K954869
Medcare Custom Packaging, Inc.
General Hospital · 87d
Cleared Nov 29, 1995
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
K954726
Stryker Endoscopy
General Hospital · 118d
Cleared Jun 13, 1995
NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM
K951119
American Hydro-Surgical Instruments, Inc.
General Hospital · 95d
Cleared Jul 28, 1993
PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS
K924337
Deknatel, Inc.
General Hospital · 335d
Cleared Jul 21, 1992
MODEL SLASE 210 HOLMIUM LASER SYSTEM
K920248
Sunrise Technologies, Inc.
General Hospital · 182d
Cleared Apr 19, 1991
COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM
K910377
CooperSurgical, Inc.
General Hospital · 80d
Cleared Mar 27, 1991
THORA-KLEX CHEST DRAINAGE UNIT
K905448
Davol, Inc.
General Hospital · 112d
Cleared Jul 16, 1990
CODMAN SUCTION PATTIE
K901937
Codman & Shurtleff, Inc.
General Hospital · 77d
Cleared Feb 08, 1990
MANIFOLD
K896804
Westmark, Sterile Packing Systems, Inc. (Sps)
General Hospital · 69d
Cleared Feb 06, 1990
UNIVERSAL POOLE SUCTION TUBE
K896556
Westmark, Sterile Packing Systems, Inc. (Sps)
General Hospital · 81d
Cleared Feb 06, 1990
YANKAUER SUCTION TUBE-FLEXIBLE TYPE
K896557
Westmark, Sterile Packing Systems, Inc. (Sps)
General Hospital · 81d
Cleared Feb 06, 1990
YANKAUER SUCTION TUBE-RIGID TYPE
K896558
Westmark, Sterile Packing Systems, Inc. (Sps)
General Hospital · 81d
Cleared Feb 06, 1990
STOPCOCK
K896562
Westmark, Sterile Packing Systems, Inc. (Sps)
General Hospital · 81d
Cleared Feb 06, 1990
TUBING CONNECTORS
K896563
Westmark, Sterile Packing Systems, Inc. (Sps)
General Hospital · 81d

About Product Code GCX - Regulatory Context