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FDA 510(k)

EXTERNAL MALE CATHETER

K-Number: K852051 · 1985-08-22

ApplicantBuffalo Medical Specialties Mfg., Inc.
Decision Date1985-08-22
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTERNAL MALE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Buffalo Medical Specialties Mfg., Inc.. It received FDA 510(k) clearance on 1985-08-22 under 510(k) number K852051. 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 EXTERNAL MALE CATHETER?

EXTERNAL MALE CATHETER is a medical device that received FDA 510(k) clearance on 1985-08-22. The listed applicant is Buffalo Medical Specialties Mfg., Inc.. The 510(k) number is K852051.

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

EXTERNAL MALE CATHETER received FDA 510(k) clearance on 1985-08-22, under 510(k) number K852051.

Who is the listed applicant for EXTERNAL MALE CATHETER?

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

What is the FDA product code for EXTERNAL MALE CATHETER?

The FDA product code for EXTERNAL MALE CATHETER is KNX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Buffalo Medical Specialties Mfg., 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.

K902132CUFF, BLOOD PRESSUREK830569CYNOX I HEMOGLOBINOMETER

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

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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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