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

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 a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2016-09-29 under approval 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. It is manufactured by Coloplast Corp.. The 510(k) number is K161672.

When was SpeediCath Flex Coude approved by the FDA?

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

What company makes SpeediCath Flex Coude?

SpeediCath Flex Coude is manufactured by Coloplast Corp..

What is the FDA product code for SpeediCath Flex Coude?

The FDA product code for SpeediCath Flex Coude is GBM.

Other Devices by Coloplast Corp.

K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTS K170531Ureteral Dilators and Percutaneous Nephrostomy Dilators K182831SabreLine and SabreGuard Laser Fibers K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent

View all 27 devices →

Related Devices (Code: GBM)

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 K180801Actreen Hi-Lite Cath, Actreen Hi-Lite SetB.Braun Medical, Inc.

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.

↑