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FDA 510(k)

URO-MALE INCONTINENCE CATHETER

K-Number: K841224 · 1984-05-02

ApplicantGil-Med Industries C/O Kegan & Kegan, Ltd.
Decision Date1984-05-02
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URO-MALE INCONTINENCE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Gil-Med Industries C/O Kegan & Kegan, Ltd.. It received FDA 510(k) clearance on 1984-05-02 under 510(k) number K841224. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URO-MALE INCONTINENCE CATHETER?

URO-MALE INCONTINENCE CATHETER is a medical device that received FDA 510(k) clearance on 1984-05-02. The listed applicant is Gil-Med Industries C/O Kegan & Kegan, Ltd.. The 510(k) number is K841224.

When did URO-MALE INCONTINENCE CATHETER receive FDA 510(k) clearance?

URO-MALE INCONTINENCE CATHETER received FDA 510(k) clearance on 1984-05-02, under 510(k) number K841224.

Who is the listed applicant for URO-MALE INCONTINENCE CATHETER?

The FDA 510(k) record lists Gil-Med Industries C/O Kegan & Kegan, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URO-MALE INCONTINENCE CATHETER?

The FDA product code for URO-MALE INCONTINENCE CATHETER is KNX.

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Other records listing Gil-Med Industries C/O Kegan & Kegan, Ltd. 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.

K880506MODIFIED EVA-MIX AND DI-MIX BAGSK870274DI-MIX PARENTERAL NUTRITION & MEDICINE CONTAINERK861862DIETO CONTAINER FOR ENTERAL NUTRITIONK841597GIL-MED PARENTERAL NUTRITION OR MEDICINEK840915DIMIX CONTAINER FOR PARNETERAL NUTRITK840916DIETO CONTAINER FOR ENTERNAL NUTRIT

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Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

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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