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FDA 510(k)

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)

K-Number: K203637 · 2022-03-08

ApplicantColoplast
Decision Date2022-03-08
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) is a medical device manufactured by Coloplast. It received FDA 510(k) clearance on 2022-03-08 under approval number K203637. 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 SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)?

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) is a medical device that received FDA 510(k) clearance on 2022-03-08. It is manufactured by Coloplast. The 510(k) number is K203637.

When was SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) approved by the FDA?

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) received FDA 510(k) clearance on 2022-03-08, under approval number K203637.

What company makes SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)?

SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) is manufactured by Coloplast.

What is the FDA product code for SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)?

The FDA product code for SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) is EZD.

Related Clinical Trials

NCT07376421 Clinical Investigation Exploring a Newly Developed Ostomy Baseplate COMPLETED

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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.

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