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 Set

K-Number: K222059 · 2022-09-21

ApplicantColoplast
Decision Date2022-09-21
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SpeediCath Flex Set is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K222059. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpeediCath Flex Set?

SpeediCath Flex Set is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Coloplast. The 510(k) number is K222059.

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

SpeediCath Flex Set received FDA 510(k) clearance on 2022-09-21, under 510(k) number K222059.

Who is the listed applicant for SpeediCath Flex Set?

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 Set?

The FDA product code for SpeediCath Flex Set is EZD.

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: EZD)

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.

K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister IncorporatedK260999LoFric Elle ProWellspect AB

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.

↑