FDA 510(k)

SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

K-Number: K070939 · 2007-06-01

ApplicantColoplast Manufacturing Us, LLC

Decision Date2007-06-01

Product CodeFCM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Manufacturing Us, LLC. It received FDA 510(k) clearance on 2007-06-01 under 510(k) number K070939. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM?

SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-01. The listed applicant is Coloplast Manufacturing Us, LLC. The 510(k) number is K070939.

When did SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM receive FDA 510(k) clearance?

SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM received FDA 510(k) clearance on 2007-06-01, under 510(k) number K070939.

Who is the listed applicant for SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM?

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

What is the FDA product code for SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM?

The FDA product code for SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM is FCM.

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Other records listing Coloplast Manufacturing Us, LLC as applicant

K100878SELF CATH CATHETER K093112DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE K082640VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM

Related Devices (Code: FCM)

K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec Limited K223821Self-Cath Closed SystemColoplast K082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, Inc.K030712AMSURE URETHRAL CATHETERIZATION TRAYAmsino International, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.