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FDA 510(k)

LINEBERGER EXTERNAL MALE CATHETER

K-Number: K800890 · 1980-06-20

ApplicantLineberger External Catheter Co.
Decision Date1980-06-20
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LINEBERGER EXTERNAL MALE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Lineberger External Catheter Co.. It received FDA 510(k) clearance on 1980-06-20 under 510(k) number K800890. 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 LINEBERGER EXTERNAL MALE CATHETER?

LINEBERGER EXTERNAL MALE CATHETER is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Lineberger External Catheter Co.. The 510(k) number is K800890.

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

LINEBERGER EXTERNAL MALE CATHETER received FDA 510(k) clearance on 1980-06-20, under 510(k) number K800890.

Who is the listed applicant for LINEBERGER EXTERNAL MALE CATHETER?

The FDA 510(k) record lists Lineberger External Catheter Co. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for LINEBERGER 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.

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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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