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FDA 510(k)

FOLEY CATHETER

K-Number: K902710 · 1990-11-21

ApplicantSocieta Gruppi Elastomeri S.A.
Decision Date1990-11-21
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Societa Gruppi Elastomeri S.A.. It received FDA 510(k) clearance on 1990-11-21 under 510(k) number K902710. 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 FOLEY CATHETER?

FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1990-11-21. The listed applicant is Societa Gruppi Elastomeri S.A.. The 510(k) number is K902710.

When did FOLEY CATHETER receive FDA 510(k) clearance?

FOLEY CATHETER received FDA 510(k) clearance on 1990-11-21, under 510(k) number K902710.

Who is the listed applicant for FOLEY CATHETER?

The FDA 510(k) record lists Societa Gruppi Elastomeri S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOLEY CATHETER?

The FDA product code for FOLEY CATHETER is EZL.

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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.

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,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.

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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