FDA 510(k) Applications for Medical Device Product Code "GCX"
(Apparatus, Suction, Operating-Room, Wall Vacuum Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K964127 ALLEGIANCE HEALTHCARE CORP. MEDI-VAC FLEXI-CLEAR SUCTION HANDLE 12/31/1996
K971022 CHASE MEDICAL, INC. CHASE SUCKER 04/17/1997
K992126 CIRCON CORP. CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM 08/03/1999
K960223 CUSTOM PACK RELIABILITY CPR YANKAUER 03/28/1996
K964519 KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH CURITY THORACENTESIS TRAY 12/20/1996
K954869 MEDCARE CUSTOM PACKAGING, INC. MEDCARE YANKAUER SUCTION DEVICE 01/19/1996
K961880 MEDCARE MEDICAL GROUP, INC. MEDCARE SUCTION CONNECTING TUBING 07/19/1996
K962920 R&S SURGICAL, LLC. RENTON SUCTION DEVICE U.S. PATENT*4,767,404 10/21/1996
K042454 Stryker Endoscopy STRYKER CASSETTE PUMP 12/09/2004
K963648 Stryker Endoscopy STRYKER SUCTION REGULATOR 11/26/1996
K972074 WALTER LORENZ SURGICAL, INC. SUCTION INSTRUMENTATION 07/25/1997


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