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510(k) K232327

Endorail by Endostart S.R.L. — Product Code ODC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2024
Date Received
August 3, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

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