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 - 00840253114372 Catalog Number : FSC330-F7523-R

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114389 Catalog Number : FSC330-F7524-R

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114396 Catalog Number : FSC330-F7525-R

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114402 Catalog Number : FSC330-F7526-R

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114419 Catalog Number : FSC330-G7520-R

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114426 Catalog Number : FSC330-G7521-R

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114433 Catalog Number : FSC330-G7522-R

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114440 Catalog Number : FSC330-G7529-R

Device Description : Colonoscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDF

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114457 Catalog Number : FSG250-H7641-R

Device Description : Gastroscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

Fuse - 00840253114464 Catalog Number : FSG250-H7642-R

Device Description : Gastroscope

Device Class : 2

Duns Number: 014154279

Premarket Exempt : No

Product Code : FDS

Prescription Use : Yes

Device Count : 1

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