TPLC - Total Product Life Cycle

• Device: apparatus, suction, operating-room, wall vacuum powered
• Regulation Description: Vacuum-powered body fluid suction apparatus.
• Product Code: GCX
• Regulation Number: 880.6740
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT WITH DRUG	1
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
APLICARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
BEMIS HEALTH CARE
	SUBSTANTIALLY EQUIVALENT	2
BOEHRINGER
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	3
CARDINAL HEALTH
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	1
COOPERSURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GISH BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPACT INSTRUMENTATION, INC.
	SUBSTANTIALLY EQUIVALENT	2
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	2
KENDALL
	SUBSTANTIALLY EQUIVALENT	4
MAXXIM MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
NELLCOR PURITAN BENNETT
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PMT CORP.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	3
W. LORENZ SURGICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Suction issue	222
Vacuum, loss of	44
Disconnection	9
Material separation	6
Use of Device Issue	2
Fluid leak	2
Leak	1
Reflux within device	1
Break	1
Crack	1
Tube(s), defective	1
Connection issue	1
Total Device Problems	291

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	0	0	0	0	1
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Endoscopy	II	May-03-2013