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510(k) K140295

GIS ENDOSCOPIC OPTICAL LENS by Gi Scientific, LLC — Product Code FDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2014
Date Received
February 6, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastroscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine or perform procedures in the stomach. 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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