TPLC - Total Product Life Cycle

• Device: nasopharyngoscope (flexible or rigid)
• Regulation Description: Nasopharyngoscope (flexible or rigid) and accessories.
• Product Code: EOB
• Regulation Number: 874.4760
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACCLARENT, INC.
	SUBSTANTIALLY EQUIVALENT	3
ENDIUS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENTELLUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
INVOTEC INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
J. JAMNER
	SUBSTANTIALLY EQUIVALENT	2
KARL STORZ GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	25
OLYMPUS
	SUBSTANTIALLY EQUIVALENT	7
OPTIM, INC.
	SUBSTANTIALLY EQUIVALENT	1
OPTUS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PENTAX
	SUBSTANTIALLY EQUIVALENT	2
PRECISION OPTICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
RICHARD WOLF
	SUBSTANTIALLY EQUIVALENT	2
RTC INC.-MEMCATH TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	1
VISION-SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	15
VISIONSENSE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
XION GMBH
	SUBSTANTIALLY EQUIVALENT	1
XOMED, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Material rupture	1
Smoking	1
Foreign material present in device	1
Scratched material	1
Temperature issue	1
Total Device Problems	5

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Vision-Sciences, Inc.	II	Jan-29-2012