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510(k) K051068

ZUTRON COLONOSCOPE STIFFENING DEVICE by Zutron Medical — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2005
Date Received
April 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

To examine or perform procedures in the colon or rectum 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 Zutron Medical

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