US Endoscopy

Address:583 N SMITH AVE STE B,Corona,CA,92880,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

SNARE, FLEXIBLE (FDI) (4) endoscopic injection needle, gastroenterology-urology (FBK) (4) Unit, electrosurgical, endoscopic (with or without accessories) (KNS) (3) Endoscopic ultrasound system, gastroenterology-urology (ODG) (2) Transducer, ultrasonic, diagnostic (ITX) (2) FORCEPS, BIOPSY, NON-ELECTRIC (FCL) (1)

Premarket Exempt

No Yes

Clear

Centra - 00724995180645 Catalog Number : 00711250

Device Description : The Centra biopsy forceps is used to enter human gastrointestinal tract via flex

Device Class : 1

Duns Number: 627879687

Premarket Exempt : Yes

Product Code : FCL

Prescription Use : Yes

Device Count : 1

NA - 00724995180683 Catalog Number : 00711841

Device Description : The Bipolar Hemostatic Probe is passed through an endoscope's working channel to

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

NA - 00724995180690 Catalog Number : 00711843

Device Description : The Bipolar Hemostatic Probe is passed through an endoscope's working channel to

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

NA - 00724995180706 Catalog Number : 00711847

Device Description : The Bipolar Hemostatic Probe is passed through an endoscope's working channel to

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

Ultramatrix - 00724995180768 Catalog Number : USBOL

Device Description : The Ultramatrix EUS balloon -Olympus linear is used for endoscopic ultrasound ap

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : ODG, ITX

Prescription Use : Yes

Device Count : 1

Ultramatrix - 00724995180775 Catalog Number : USBOR

Device Description : Ultramatrix EUS balloon-Olympus Pentax radial is used for endoscopic ultrasound

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : ODG, ITX

Prescription Use : Yes

Device Count : 1

iSnare - 00724995180782 Catalog Number : 00711084

Device Description : The iSnare system-Lariat snare is used to inject various types of media and to g

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : FDI, FBK

Prescription Use : Yes

Device Count : 1

iSnare - 00724995180799 Catalog Number : 00711085

Device Description : The iSnare system is a dual lumen device providing both needle injection and mon

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : FBK, FDI

Prescription Use : Yes

Device Count : 1

iSnare - 00724995180805 Catalog Number : 00711086

Device Description : The iSnare oval system is a dual lumen device providing both needle injection an

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : FBK, FDI

Prescription Use : Yes

Device Count : 1

iSnare - 00724995180812 Catalog Number : 00711088

Device Description : The iSnare hexagonal system is a dual lumen device providing both needle injecti

Device Class : 2

Duns Number: 627879687

Premarket Exempt : No

Product Code : FDI, FBK

Prescription Use : Yes

Device Count : 1

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