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FDA 510(k)

Yikang Latex Foley Catheter

K-Number: K173340 · 2018-07-13

ApplicantJiangxi Yikang Medical Instrument Group Co., Ltd.
Decision Date2018-07-13
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Yikang Latex Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Yikang Medical Instrument Group Co., Ltd.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K173340. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yikang Latex Foley Catheter?

Yikang Latex Foley Catheter is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Jiangxi Yikang Medical Instrument Group Co., Ltd.. The 510(k) number is K173340.

When did Yikang Latex Foley Catheter receive FDA 510(k) clearance?

Yikang Latex Foley Catheter received FDA 510(k) clearance on 2018-07-13, under 510(k) number K173340.

Who is the listed applicant for Yikang Latex Foley Catheter?

The FDA 510(k) record lists Jiangxi Yikang Medical Instrument Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yikang Latex Foley Catheter?

The FDA product code for Yikang Latex Foley Catheter is EZL.

Other records listing Jiangxi Yikang Medical Instrument Group Co., Ltd. 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.

K190213Yikang Endotracheal Tube

Related Devices (Code: EZL)

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.

K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, Inc.K240057TraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLC

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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