Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SpeediCath Flex Coude Pro

K-Number: K180070 · 2018-02-02

ApplicantColoplast
Decision Date2018-02-02
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SpeediCath Flex Coude Pro is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K180070. 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 Pro?

SpeediCath Flex Coude Pro is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is Coloplast. The 510(k) number is K180070.

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

SpeediCath Flex Coude Pro received FDA 510(k) clearance on 2018-02-02, under 510(k) number K180070.

Who is the listed applicant for SpeediCath Flex Coude Pro?

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 Flex Coude Pro?

The FDA product code for SpeediCath Flex Coude Pro 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.

PMA P000006Device, impotence, mechanical/hydraulicPMA P020003Prosthesis, testicularK252140Heylo™ SystemK251116Luja CoudéK250270Luja SetK242049SureCath Set

View all 42 devices →

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.

↑