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510(k) K071254

SMALL INTESTINAL VIDEOSCOPE SYSTEM by Olympus Medical Systems Corporation — Product Code FDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2008
Date Received
May 4, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enteroscope And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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