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510(k) K032177

GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I by Olympus Opto-Electronics Co., Ltd. — Product Code FDS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2003
Date Received
July 16, 2003
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).

Other clearances by Olympus Opto-Electronics Co., Ltd.

  • K031256 — XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE (July 23, 2003)

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