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FDA 510(k)

EXTERNAL URINARY MALE INCONTINENCE DEV

K-Number: K821161 · 1982-05-10

ApplicantThe Healthcare Group Laboratories, Inc.
Decision Date1982-05-10
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTERNAL URINARY MALE INCONTINENCE DEV is the device name listed in this FDA 510(k) record. The listed applicant is The Healthcare Group Laboratories, Inc.. It received FDA 510(k) clearance on 1982-05-10 under 510(k) number K821161. 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 URINARY MALE INCONTINENCE DEV?

EXTERNAL URINARY MALE INCONTINENCE DEV is a medical device that received FDA 510(k) clearance on 1982-05-10. The listed applicant is The Healthcare Group Laboratories, Inc.. The 510(k) number is K821161.

When did EXTERNAL URINARY MALE INCONTINENCE DEV receive FDA 510(k) clearance?

EXTERNAL URINARY MALE INCONTINENCE DEV received FDA 510(k) clearance on 1982-05-10, under 510(k) number K821161.

Who is the listed applicant for EXTERNAL URINARY MALE INCONTINENCE DEV?

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

What is the FDA product code for EXTERNAL URINARY MALE INCONTINENCE DEV?

The FDA product code for EXTERNAL URINARY MALE INCONTINENCE DEV is KNX.

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Other records listing The Healthcare Group Laboratories, 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.

K850035EMPTY SOLUTION TRANSFER CONTAINERK842170EMPTY SOLUTION TRANSFER CONTAINERK842091DISPOS. ACU-CUT SOFT TISSUE BIOPSYK840742RIGHT ATRIAL CATHETERK830299SOLUTION TRANSFER CONTAINERK822307ADHESIVE SPRAY #4050-4060

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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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