GCX · Class II · 21 CFR 880.6740

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

Leading manufacturers include Deknatel, Inc., Sorensen Research 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 Jul 25, 1997
SUCTION INSTRUMENTATION
K972074
Walter Lorenz Surgical, Inc.
General Hospital · 52d
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 Nov 29, 1995
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
K954726
Stryker Endoscopy
General Hospital · 118d
Cleared Jul 28, 1993
PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS
K924337
Deknatel, Inc.
General Hospital · 335d
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 Aug 21, 1989
MECONIUM ASPIRATOR
K893649
Gish Biomedical, Inc.
General Hospital · 98d
Cleared Aug 17, 1989
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741
Abbott Laboratories
General Hospital · 92d
Cleared May 18, 1989
SUCTION TUBES: HOUSE, BARON
K892549
Zinnanti Surgical Instruments, Inc.
General Hospital · 37d
Cleared Apr 10, 1989
PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM
K890129
Deknatel, Inc.
General Hospital · 88d
Cleared Apr 04, 1989
PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN
K890431
Deknatel, Inc.
General Hospital · 67d
Cleared Mar 17, 1989
RECEPTAL SAF-GARD(TM) SYSTEM
K885208
Abbott Laboratories
General Hospital · 88d
Cleared Mar 08, 1989
VAC-RITE
K885334
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 70d
Cleared Mar 03, 1989
REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES
K884103
Boehringer Laboratories
General Hospital · 155d
Cleared Jun 17, 1988
PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE
K881252
Deknatel, Inc.
General Hospital · 86d
Cleared May 30, 1986
OHMEDA POSI-PULSE SUCTION UNIT
K861261
Ohmeda Medical
General Hospital · 56d
Cleared Aug 23, 1985
BOEHRINGER LABORATORIES SUCTION INTERMITTOR
K853095
Boehringer Laboratories
General Hospital · 31d
Cleared May 08, 1985
MEDICAL/SURGICAL SUCTION SYSTEM
K851384
Puritan Bennett Corp.
General Hospital · 29d
Cleared Jan 25, 1984
ACCURATE MEASUREMENT DEVICE KG-AMD
K833674
Sorensen Research
General Hospital · 99d
Cleared Dec 29, 1983
ACCURATE MEASUREMENT DEVICE EZ-AMD
K833673
Sorensen Research
General Hospital · 72d

About Product Code GCX - Regulatory Context