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

Gastroscope And Accessories, Flexible/Rigid (FDS) (2) Colonoscope And Accessories, Flexible/Rigid (FDF) (1) Endoscopic Irrigation/Suction System (OCX) (1)

Premarket Exempt

Clear

Fuse - 00840253114570 Catalog Number : FSC330-C6339-R

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114587 Catalog Number : FSG-2500-MC90-R

Device Description : Gastroscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114594 Catalog Number : FSG-2500-ST-R

Device Description : Gastroscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

Seal® - 10840253110067 Catalog Number :

Device Description : Biopsy Valve

Device Class :

Duns Number: 014154279

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 100

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