TPLC - Total Product Life Cycle

Device	unit, cryosurgical, accessories
Regulation Description	Cryosurgical unit and accessories.
Product Code	GEH
Regulation Number	878.4350
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARBEL MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
ATRICURE, INC.
	SUBSTANTIALLY EQUIVALENT	4
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BRYMILL CORP.
	SUBSTANTIALLY EQUIVALENT	1
CANDELA CORP.
	SUBSTANTIALLY EQUIVALENT	3
CRYOCATH TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
CRYOGEN, INC.
	SUBSTANTIALLY EQUIVALENT	2
CRYOSURGERY, INC.
	SUBSTANTIALLY EQUIVALENT	3
CSA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
ELLMAN INT'L INC.
	SUBSTANTIALLY EQUIVALENT	1
ENDOCARE, INC.
	SUBSTANTIALLY EQUIVALENT	13
ERBE ELEKTROMEDIZIN GMBH
	SUBSTANTIALLY EQUIVALENT	1
ETGAR GROUP H.M.Y.A. LTD.
	SUBSTANTIALLY EQUIVALENT	1
GALIL MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	20
MYOSCIENCE INC
	SUBSTANTIALLY EQUIVALENT	1
ORASURE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	6
SANARUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	7
SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPEMBLY CRYOSURGERY
	SUBSTANTIALLY EQUIVALENT	8
VALLEYLAB
	SUBSTANTIALLY EQUIVALENT	2
WALLACH SURGICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	5
WARTNER MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Other (for use when an appropriate device code cannot be identified)	3
Device handling issue	2
No Known Device Problem	1
Bent	1
Fire	1
Mechanical issue	1
Reaction	1
Tip breakage	1
Total Device Problems	11

Recalls
Manufacturer		Recall Class	Date Posted
1	Cooper Surgical, Inc.	II	Oct-29-2009
2	Endocare, Division Of Healthtronics	II	Dec-13-2010
3	Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.	II	Apr-16-2010
4	Galil Medical	II	Dec-29-2010
5	Galil Medical	II	Sep-03-2008
6	Galil Medical, Inc.	II	Aug-23-2012
7	Galil Medical, Inc.	II	May-16-2012
8	Galil Medical, Inc.	II	Feb-03-2011
9	Healthtronics, Inc.	II	Feb-15-2013
10	Healthtronics, Inc.	II	Mar-21-2012
11	Wallach Surgical Devices, Inc.	II	Jul-11-2007