Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Urethrotech UCD

K-Number: K190060 · 2019-10-04

ApplicantUrethrotech
Decision Date2019-10-04
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Urethrotech UCD is the device name listed in this FDA 510(k) record. The listed applicant is Urethrotech. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K190060. 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 Urethrotech UCD?

Urethrotech UCD is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Urethrotech. The 510(k) number is K190060.

When did Urethrotech UCD receive FDA 510(k) clearance?

Urethrotech UCD received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190060.

Who is the listed applicant for Urethrotech UCD?

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

What is the FDA product code for Urethrotech UCD?

The FDA product code for Urethrotech UCD is EZL.

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

View on FDA Database →

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

↑