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FDA 510(k)

MALE URINARY CATHETER, EXTERNAL

K-Number: K761059 · 1976-12-02

ApplicantIntermed, Inc.
Decision Date1976-12-02
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MALE URINARY CATHETER, EXTERNAL is the device name listed in this FDA 510(k) record. The listed applicant is Intermed, Inc.. It received FDA 510(k) clearance on 1976-12-02 under 510(k) number K761059. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALE URINARY CATHETER, EXTERNAL?

MALE URINARY CATHETER, EXTERNAL is a medical device that received FDA 510(k) clearance on 1976-12-02. The listed applicant is Intermed, Inc.. The 510(k) number is K761059.

When did MALE URINARY CATHETER, EXTERNAL receive FDA 510(k) clearance?

MALE URINARY CATHETER, EXTERNAL received FDA 510(k) clearance on 1976-12-02, under 510(k) number K761059.

Who is the listed applicant for MALE URINARY CATHETER, EXTERNAL?

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

What is the FDA product code for MALE URINARY CATHETER, EXTERNAL?

The FDA product code for MALE URINARY CATHETER, EXTERNAL is KOD.

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Other records listing Intermed, 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.

K900857NON STERILE PARENTERAL SUPPLY KITK842166INTERMED, INS STERILE WATER/SALINEK833126DRESSING CHANGE TRAYSK833574PERCUTANEOUS SHEATH INTRODUCER TRAYSK833573CENTRAL VEIN CATH. TRAY CC-20-1420K833139ACUTE HEMODIALYSIS TRAYS

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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