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) (8) Gastroscope And Accessories, Flexible/Rigid (FDS) (2)

Premarket Exempt

Clear

FuseBox - 00840253104267 Catalog Number : LS-FSP-100

Device Description : Endoscopic Video Processor Unit

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

FuseBox - 00840253104274 Catalog Number : LS-FSP-100-AR

Device Description : Endoscopic Video Processor Unit

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253109521 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253109538 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253109545 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253109552 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253109576 Catalog Number : FSC330-F7528

Device Description : Fuse C38 Colonoscope (150 cm)

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253109583 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253109590 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253109606 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

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