TPLC - Total Product Life Cycle

Device	cannula, manipulator/injector, uterine
Product Code	LKF
Device Class	Unclassified

Premarket Reviews
Manufacturer	Decision
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CATHETER RESEARCH, INC.
	SUBSTANTIALLY EQUIVALENT	4
CLINICAL INNOVATIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
CONCEPTUS, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONMED
	SUBSTANTIALLY EQUIVALENT	4
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	3
FEMASYS INC.
	SUBSTANTIALLY EQUIVALENT	4
INTUITIVE SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
IRVINE SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
MARINA MEDICAL INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL DEVICE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MODERN MEDICAL EQUIPMENT MFG., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OBG PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
PANPAC MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
PROSURG, INC.
	SUBSTANTIALLY EQUIVALENT	1
THOMAS MEDICAL PRODUCTS, INC
	SUBSTANTIALLY EQUIVALENT	1
UNIMAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
UTAH MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Inflation issue	3
Tear, rip or hole in device packaging	3
Hole in material	2
Break	2
Burst	1
Detachment of device component	1
Component falling	1
Crack	1
Replace	1
Unraveled material	1
Total Device Problems	16