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

Fuse® - 00840253110800 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253110817 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253110824 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253110831 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253110848 Catalog Number :

Device Description : Gastroscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253111043 Catalog Number :

Device Description : Gastroscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253111050 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253111067 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253111074 Catalog Number :

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse® - 00840253111081 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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