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 a medical device manufactured by Coloplast. It received FDA 510(k) clearance on 2018-02-02 under approval 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. It is manufactured by Coloplast. The 510(k) number is K180070.
When was SpeediCath Flex Coude Pro approved by the FDA?
SpeediCath Flex Coude Pro received FDA 510(k) clearance on 2018-02-02, under approval number K180070.
What company makes SpeediCath Flex Coude Pro?
SpeediCath Flex Coude Pro is manufactured by Coloplast.
What is the FDA product code for SpeediCath Flex Coude Pro?
The FDA product code for SpeediCath Flex Coude Pro is GBM.
Related Clinical Trials
Other Devices by Coloplast
Related Devices (Code: GBM)
K161672SpeediCath Flex CoudeColoplast Corp.
K160795United Urologics Intermittent CatheterRobling Medical
K151772Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc.
K172278Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated
K163179Onli Intermittent CatheterHollister Incorporated
K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated
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.