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FDA 510(k)

SpeedCath Compact Male

K-Number: K210250 · 2022-04-26

ApplicantColoplast
Decision Date2022-04-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SpeedCath Compact Male is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2022-04-26 under 510(k) number K210250. 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 SpeedCath Compact Male?

SpeedCath Compact Male is a medical device that received FDA 510(k) clearance on 2022-04-26. The listed applicant is Coloplast. The 510(k) number is K210250.

When did SpeedCath Compact Male receive FDA 510(k) clearance?

SpeedCath Compact Male received FDA 510(k) clearance on 2022-04-26, under 510(k) number K210250.

Who is the listed applicant for SpeedCath Compact Male?

The FDA 510(k) record lists Coloplast as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpeedCath Compact Male?

The FDA product code for SpeedCath Compact Male is EZD.

Other records listing Coloplast as applicant

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.

View all 42 devices →

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.

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.