FDA 510(k)

SpeediCath Standard

K-Number: K180258 · 2018-10-25

Decision Date2018-10-25

Product CodeGBM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SpeediCath Standard is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K180258. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpeediCath Standard?

SpeediCath Standard is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Coloplast. The 510(k) number is K180258.

When did SpeediCath Standard receive FDA 510(k) clearance?

SpeediCath Standard received FDA 510(k) clearance on 2018-10-25, under 510(k) number K180258.

Who is the listed applicant for SpeediCath Standard?

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 SpeediCath Standard?

The FDA product code for SpeediCath Standard is GBM.

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.

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Related Devices (Code: GBM)

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited K211436Intermittent Catheter (Not Finalized)Hollister Incorporated K200820SpeediCath Compact SetColoplast K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast

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.