DIROS TECHNOLOGY, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
8043398	3003630373	DIROS TECHNOLOGY, INC.	1	N	2026-01-01	120 GIBSON DRIVE MARKHAM Ontario CA L3R 2Z3

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
42906	1952728973	K170708	OWL RF INSULATED CANNULAE	GXI	2017-06-27
42906	1510319803	K150371	Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH	GXI	2015-07-30
42906	1894200823	K141586	OWL CANNULAE	GXI	2014-12-30
42906	1472252431	K110593	OWL RF PROBES	GXI	2011-05-05
42906	1508731725	K102566	OWL CANNULAE	GXI	2011-06-03
42906	1012556039	K093185	OWL UNIVERSAL RF SYSTEM URF-3AP (ML)	GXD	2010-01-22
42906	1329098225	K073360	PROPLATE	GEI	2007-12-19
42906	1379513871	K062758	OWL URF-3AP	GXD	2006-09-27
42906	1251382670	K021869	OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP	GXD	2002-07-01
42906	1379285504	K010202	OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES	GXD	2001-10-31
42906	1226685132
42906	1376050855

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GXI	5	2017-06-27
GXD	4	2010-01-22
GEI	1	2007-12-19

PMN#

Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR And DTRH
2015-07-30
DIROS TECHNOLOGY, INC.
OWL CANNULAE
2014-12-30
DIROS TECHNOLOGY, INC.
OWL CANNULAE
2011-06-03
DIROS TECHNOLOGY, INC.
OWL RF PROBES
2011-05-05
DIROS TECHNOLOGY, INC.
OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
2010-01-22
DIROS TECHNOLOGY, INC.
OWL URF-3AP
2006-09-27
DIROS TECHNOLOGY, INC.
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
2002-07-01
DIROS TECHNOLOGY, INC.