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510(k) K191715

Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile by STERIS Corporation — Product Code OCU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2020
Date Received
June 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Storage Cover
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.

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