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FDA 510(k)

ASSURE-MALE EXTERNAL INCONTINCE CATHETER

K-Number: K821848 · 1982-08-10

ApplicantMedical Design & Manufacturing Corp.
Decision Date1982-08-10
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASSURE-MALE EXTERNAL INCONTINCE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Design & Manufacturing Corp.. It received FDA 510(k) clearance on 1982-08-10 under 510(k) number K821848. 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 ASSURE-MALE EXTERNAL INCONTINCE CATHETER?

ASSURE-MALE EXTERNAL INCONTINCE CATHETER is a medical device that received FDA 510(k) clearance on 1982-08-10. The listed applicant is Medical Design & Manufacturing Corp.. The 510(k) number is K821848.

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

ASSURE-MALE EXTERNAL INCONTINCE CATHETER received FDA 510(k) clearance on 1982-08-10, under 510(k) number K821848.

Who is the listed applicant for ASSURE-MALE EXTERNAL INCONTINCE CATHETER?

The FDA 510(k) record lists Medical Design & Manufacturing Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASSURE-MALE EXTERNAL INCONTINCE CATHETER?

The FDA product code for ASSURE-MALE EXTERNAL INCONTINCE CATHETER is KNX.

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Other records listing Medical Design & Manufacturing Corp. 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.

K911911MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEMK914384MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODEK911366PROTECTOR DISPOSABLE TENS AND NMES ELECTRODEK902822MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICEK895604SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODESK880492INTERCEPT T.E.N.S. DEVICE

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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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