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FDA 510(k)

HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT

K-Number: K062444 · 2007-02-22

ApplicantOasis Medikal Urunler Kimya Sanayi VE Tic A.S.
Decision Date2007-02-22
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT is the device name listed in this FDA 510(k) record. The listed applicant is Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.. It received FDA 510(k) clearance on 2007-02-22 under 510(k) number K062444. 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 HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT?

HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT is a medical device that received FDA 510(k) clearance on 2007-02-22. The listed applicant is Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.. The 510(k) number is K062444.

When did HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT receive FDA 510(k) clearance?

HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT received FDA 510(k) clearance on 2007-02-22, under 510(k) number K062444.

Who is the listed applicant for HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT?

The FDA 510(k) record lists Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT?

The FDA product code for HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT is EZD.

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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.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure 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 Incorporated

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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