FDA 510(k) Applications for Medical Device Product Code "OCU"
(Endoscopic Storage Cover)

FDA 510(k) Number Applicant Device Name Decision Date
K030684 ACMI CORPORATION SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH 06/03/2003
K202838 GA Health Company Limited Andorate Universal Endoscope Tip Guard 03/05/2021
K191011 Meditech Endoscopy Ltd Scope ProTech 05/07/2019
K191715 STERIS Corporation Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile 01/27/2020


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