TPLC - Total Product Life Cycle

Device	sterilization wrap containers, trays, cassettes & other accessories
Regulation Description	Sterilization wrap.
Product Code	KCT
Regulation Number	880.6850
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADROIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED STERILIZATION PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP
	SUBSTANTIALLY EQUIVALENT	1
BAHADIR USA CORP.
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CASE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONMED
	SUBSTANTIALLY EQUIVALENT	4
CONTAINMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
CURRIE MEDICAL SPECIALTIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENTELLUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ETHOX INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
GYRUS ACMI, INC.
	SUBSTANTIALLY EQUIVALENT	3
HOLOGIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
INTUITIVE SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
KIMBERLY-CLARK CORP.
	SUBSTANTIALLY EQUIVALENT	1
MAXXIM MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MICROMEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MILTEX
	SUBSTANTIALLY EQUIVALENT	4
	SUBSTANTIALLY EQUIVALENT - KIT	1
OLYMPUS
	SUBSTANTIALLY EQUIVALENT	2
SKLAR
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	7
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
T.A.G. MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Other (for use when an appropriate device code cannot be identified)	4
Use of Device Issue	3
Melted	1
Defective item	1
No code available	1
Total Device Problems	10

Recalls
Manufacturer		Recall Class	Date Posted
1	Advanced Sterilization Products	II	Feb-22-2011
2	Smith & Nephew, Inc. Endoscopy Division	II	Jun-24-2011
3	Stryker Endoscopy	II	Jun-22-2011