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FDA 510(k)

URI-CATH CATHETER

K-Number: K941672 · 1994-05-16

ApplicantGesco Intl., Inc.
Decision Date1994-05-16
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URI-CATH CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Gesco Intl., Inc.. It received FDA 510(k) clearance on 1994-05-16 under 510(k) number K941672. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URI-CATH CATHETER?

URI-CATH CATHETER is a medical device that received FDA 510(k) clearance on 1994-05-16. The listed applicant is Gesco Intl., Inc.. The 510(k) number is K941672.

When did URI-CATH CATHETER receive FDA 510(k) clearance?

URI-CATH CATHETER received FDA 510(k) clearance on 1994-05-16, under 510(k) number K941672.

Who is the listed applicant for URI-CATH CATHETER?

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

What is the FDA product code for URI-CATH CATHETER?

The FDA product code for URI-CATH CATHETER is GBM.

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Other records listing Gesco Intl., Inc. 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.

K954422PER-Q-CATH MID-LINEK940870UMBILI-CATHK940953UMBILI-CATH-SK940952UMBILI-CATH-S-DLK941232THORA-CATHK940871UMBILI-CATH-P

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Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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.

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