Olympus Medical Products Czech

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3007960282	3007960282	Olympus Medical Products Czech	1	N	2020-04-25	Ul Telickova 457/29 Prerov II Predmosti Prerov CZ 75124

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
110372	1988414566	K954488	ROLLER ELECTRODE	HIH	1997-03-06
110372	1225631718	K951863	ROLLER ELECTRODE	FAS	1995-08-24
110372	1734518701	K931764	HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES	HIH	1994-06-08
110372	1757062860	K931763	HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS	FAS	1994-08-29
110372	2057428059	K904939	FLEXIBLE AND RIGID URETEROTOME SYSTEM	EZO	1992-01-07
110372	1767439049	K903323	RESECTOSCOPE LOOPS	KNS	1990-10-01
110372	1842009307	K172535	Bipolar applicator CELON ProCurve V	GEI	2017-11-16
110372	1990460187	K171965	Resection Electrodes with HF cable	FAS	2017-09-28
110372	1645169926	K161600	Resection Electrodes	JOS	2016-09-06
110372	1756287465	K152092	Resection Electrodes	FAS	2015-10-26
110372	1599385754	K120418	ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES	FAS	2012-06-20
110372	1066722809	K102781	RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS	FAS	2011-01-11
110372	1874798230	K100275	WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS	FAS	2010-07-01
110372	1935293283	K073207	OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167	GEI	2008-05-08
110372	1224257159	K032838	CELON ENT SYSTEM	GEI	2003-09-26
110372	2001481501	K030194	XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT	KNS	2003-03-24

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FAS	7	2017-09-28
GEI	3	2017-11-16
KNS	2	2003-03-24
HIH	2	1997-03-06
JOS	1	2016-09-06
EZO	1	1992-01-07