SUPERCATH 6
K-Number: K160592 · 2016-08-12
ApplicantTogo Medikit Co., Ltd.
Decision Date2016-08-12
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SUPERCATH 6 is a medical device manufactured by Togo Medikit Co., Ltd.. It received FDA 510(k) clearance on 2016-08-12 under approval number K160592. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SUPERCATH 6?
SUPERCATH 6 is a medical device that received FDA 510(k) clearance on 2016-08-12. It is manufactured by Togo Medikit Co., Ltd.. The 510(k) number is K160592.
When was SUPERCATH 6 approved by the FDA?
SUPERCATH 6 received FDA 510(k) clearance on 2016-08-12, under approval number K160592.
What company makes SUPERCATH 6?
SUPERCATH 6 is manufactured by Togo Medikit Co., Ltd..
What is the FDA product code for SUPERCATH 6?
The FDA product code for SUPERCATH 6 is FOZ.
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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.