Super Sheath
K-Number: K200379 · 2020-03-19
ApplicantTogo Medikit Co., Ltd.
Decision Date2020-03-19
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Super Sheath is a medical device manufactured by Togo Medikit Co., Ltd.. It received FDA 510(k) clearance on 2020-03-19 under approval number K200379. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Super Sheath?
Super Sheath is a medical device that received FDA 510(k) clearance on 2020-03-19. It is manufactured by Togo Medikit Co., Ltd.. The 510(k) number is K200379.
When was Super Sheath approved by the FDA?
Super Sheath received FDA 510(k) clearance on 2020-03-19, under approval number K200379.
What company makes Super Sheath?
Super Sheath is manufactured by Togo Medikit Co., Ltd..
What is the FDA product code for Super Sheath?
The FDA product code for Super Sheath is DRE.
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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.