Decision Date2020-09-30
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Wiygul Catheter is a medical device manufactured by Big Blue Biotech, Inc.. It received FDA 510(k) clearance on 2020-09-30 under approval number K202566. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Wiygul Catheter?
Wiygul Catheter is a medical device that received FDA 510(k) clearance on 2020-09-30. It is manufactured by Big Blue Biotech, Inc.. The 510(k) number is K202566.
When was Wiygul Catheter approved by the FDA?
Wiygul Catheter received FDA 510(k) clearance on 2020-09-30, under approval number K202566.
What company makes Wiygul Catheter?
Wiygul Catheter is manufactured by Big Blue Biotech, Inc..
What is the FDA product code for Wiygul Catheter?
The FDA product code for Wiygul Catheter is EZD.
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Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.