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FDA 510(k)

UROLOGICAL CATHETER

K-Number: K992137 · 1999-09-03

ApplicantApogee, Inc.
Decision Date1999-09-03
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROLOGICAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Apogee, Inc.. It received FDA 510(k) clearance on 1999-09-03 under 510(k) number K992137. 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 UROLOGICAL CATHETER?

UROLOGICAL CATHETER is a medical device that received FDA 510(k) clearance on 1999-09-03. The listed applicant is Apogee, Inc.. The 510(k) number is K992137.

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

UROLOGICAL CATHETER received FDA 510(k) clearance on 1999-09-03, under 510(k) number K992137.

Who is the listed applicant for UROLOGICAL CATHETER?

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

What is the FDA product code for UROLOGICAL CATHETER?

The FDA product code for UROLOGICAL CATHETER is GBM.

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Other records listing Apogee, Inc. as applicant

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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

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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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