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FDA 510(k)

CompactCath Intermittent Urinary Catheter

K-Number: K160858 · 2016-04-26

ApplicantCompactcath, Inc.
Decision Date2016-04-26
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CompactCath Intermittent Urinary Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Compactcath, Inc.. It received FDA 510(k) clearance on 2016-04-26 under 510(k) number K160858. 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 CompactCath Intermittent Urinary Catheter?

CompactCath Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2016-04-26. The listed applicant is Compactcath, Inc.. The 510(k) number is K160858.

When did CompactCath Intermittent Urinary Catheter receive FDA 510(k) clearance?

CompactCath Intermittent Urinary Catheter received FDA 510(k) clearance on 2016-04-26, under 510(k) number K160858.

Who is the listed applicant for CompactCath Intermittent Urinary Catheter?

The FDA 510(k) record lists Compactcath, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CompactCath Intermittent Urinary Catheter?

The FDA product code for CompactCath Intermittent Urinary Catheter is EZD.

Related Clinical Trials

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.

NCT07714694Consumer Evaluation of an Investigational Intermittent CatheterRECRUITING

Other records listing Compactcath, Inc. 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.

K180738COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter

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

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

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