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FDA 510(k)

SpeediCath Flex Coude

K-Number: K161672 · 2016-09-29

ApplicantColoplast Corp.
Decision Date2016-09-29
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SpeediCath Flex Coude is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K161672. 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 Flex Coude?

SpeediCath Flex Coude is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Coloplast Corp.. The 510(k) number is K161672.

When did SpeediCath Flex Coude receive FDA 510(k) clearance?

SpeediCath Flex Coude received FDA 510(k) clearance on 2016-09-29, under 510(k) number K161672.

Who is the listed applicant for SpeediCath Flex Coude?

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

What is the FDA product code for SpeediCath Flex Coude?

The FDA product code for SpeediCath Flex Coude is GBM.

Other records listing Coloplast Corp. 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)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath 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.

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