ENDOCHOICE, INC.

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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

Colonoscope And Accessories, Flexible/Rigid (FDF) (3) Endoscopic Injection Needle, Gastroenterology-Urology (FBK) (2) Gastroscope And Accessories, Flexible/Rigid (FDS) (2) Endoscopic Grasping/Cutting Instrument, Non-Powered (OCZ) (1) Endoscopic Irrigation/Suction System (OCX) (1) Snare, Flexible (FDI) (1)

Premarket Exempt

Clear

Rescue® - 00816849017341 Catalog Number :

Device Description : Rat tooth Grasping Forceps - Pediatric

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : OCZ

Prescription Use : Yes

Device Count : 5

Boa® - 00816849017600 Catalog Number :

Device Description : Polypectomy Snare, Stiff Wire

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDI

Prescription Use : Yes

Device Count : 10

Neptune® - 00816849019253 Catalog Number :

Device Description : 22 Gauge (0.7 mm) Injection Needle

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 10

Neptune® - 00816849019277 Catalog Number :

Device Description : 25 Gauge (0.5 mm) Injection Needle

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 10

Fuse® - 00816849019666 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00816849019680 Catalog Number :

Device Description : Endoscopic Processor Unit

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

Seal® - 00840253101068 Catalog Number :

Device Description : Biopsy Valve

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 10

Fuse® - 00840253101211 Catalog Number :

Device Description : Water bottle cap, reusable

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253101228 Catalog Number :

Device Description : Water bottle cap with CO2, Reusable

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

FuseBox - 00840253103932 Catalog Number : FSP-100-AR

Device Description : Endoscopic video image processor

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

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