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FDA 510(k)

URINARY CATHETERS

K-Number: K031409 · 2003-06-17

ApplicantPromedic, Inc.
Decision Date2003-06-17
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINARY CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Promedic, Inc.. It received FDA 510(k) clearance on 2003-06-17 under 510(k) number K031409. 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 URINARY CATHETERS?

URINARY CATHETERS is a medical device that received FDA 510(k) clearance on 2003-06-17. The listed applicant is Promedic, Inc.. The 510(k) number is K031409.

When did URINARY CATHETERS receive FDA 510(k) clearance?

URINARY CATHETERS received FDA 510(k) clearance on 2003-06-17, under 510(k) number K031409.

Who is the listed applicant for URINARY CATHETERS?

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

What is the FDA product code for URINARY CATHETERS?

The FDA product code for URINARY CATHETERS is GBM.

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Other records listing Promedic, 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.

K112318CLEARPATH 24K072756NON-IV ADAPTER FOR INFANT NG TUBEK060497BABYAIRK060842REVJET TURBOK052903PEDIATRIC FEEDING TUBEK024190FENESTRATED INFUSION CATHETER

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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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