Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AKRON MALE EXTERNAL CATHETER

K-Number: K781433 · 1978-11-03

ApplicantLatex Ind., Inc.
Decision Date1978-11-03
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AKRON MALE EXTERNAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Latex Ind., Inc.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781433. 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 AKRON MALE EXTERNAL CATHETER?

AKRON MALE EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Latex Ind., Inc.. The 510(k) number is K781433.

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

AKRON MALE EXTERNAL CATHETER received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781433.

Who is the listed applicant for AKRON MALE EXTERNAL CATHETER?

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

What is the FDA product code for AKRON MALE EXTERNAL CATHETER?

The FDA product code for AKRON MALE EXTERNAL 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 Latex Ind., 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.

K812058AKRON URINARY DRAINAGE BATK810281UROLOGICAL CATHETERSK791674BLADDER RETENTION CATHETERIZATION TRAYK781751CATHETER, AKRON FOLEY TEFLONK772277BLADDER RETENTION-CATHETHERIZATIONTRAYK772340CATHETERIZATION KIT 732016-732018

View all 14 devices →

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.

↑