Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
K-Number: K191715 · 2020-01-27
ApplicantSTERIS Corporation
Decision Date2020-01-27
Product CodeOCU
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2020-01-27 under approval number K191715. The device is classified under product code OCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile?
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile is a medical device that received FDA 510(k) clearance on 2020-01-27. It is manufactured by STERIS Corporation. The 510(k) number is K191715.
When was Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile approved by the FDA?
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile received FDA 510(k) clearance on 2020-01-27, under approval number K191715.
What company makes Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile?
Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile is manufactured by STERIS Corporation.
What is the FDA product code for Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile?
The FDA product code for Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile is OCU.
Other Devices by STERIS Corporation
Related Devices (Code: OCU)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.