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FDA 510(k)

Wiygul Catheter

K-Number: K202566 · 2020-09-30

ApplicantBig Blue Biotech, Inc.
Decision Date2020-09-30
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Wiygul Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Big Blue Biotech, Inc.. It received FDA 510(k) clearance on 2020-09-30 under 510(k) 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. The listed applicant is Big Blue Biotech, Inc.. The 510(k) number is K202566.

When did Wiygul Catheter receive FDA 510(k) clearance?

Wiygul Catheter received FDA 510(k) clearance on 2020-09-30, under 510(k) number K202566.

Who is the listed applicant for Wiygul Catheter?

The FDA 510(k) record lists Big Blue Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wiygul Catheter?

The FDA product code for Wiygul Catheter is EZD.

Related Devices (Code: EZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister IncorporatedK260999LoFric Elle ProWellspect AB

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.

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