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FDA 510(k)

Kohli Urinary Drainage Catheter

K-Number: K172422 · 2018-02-09

ApplicantNellie Medical, LLC
Decision Date2018-02-09
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Kohli Urinary Drainage Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nellie Medical, LLC. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172422. 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 Kohli Urinary Drainage Catheter?

Kohli Urinary Drainage Catheter is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Nellie Medical, LLC. The 510(k) number is K172422.

When did Kohli Urinary Drainage Catheter receive FDA 510(k) clearance?

Kohli Urinary Drainage Catheter received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172422.

Who is the listed applicant for Kohli Urinary Drainage Catheter?

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

What is the FDA product code for Kohli Urinary Drainage Catheter?

The FDA product code for Kohli Urinary Drainage Catheter is EZL.

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 CatheterRECRUITINGNCT07782762Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)RECRUITING

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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