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FDA 510(k)

COLOPLAST BABY URINE COLLECTORS

K-Number: K833570 · 1984-01-30

ApplicantColoplast A/S
Decision Date1984-01-30
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLOPLAST BABY URINE COLLECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 1984-01-30 under 510(k) number K833570. 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 COLOPLAST BABY URINE COLLECTORS?

COLOPLAST BABY URINE COLLECTORS is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is Coloplast A/S. The 510(k) number is K833570.

When did COLOPLAST BABY URINE COLLECTORS receive FDA 510(k) clearance?

COLOPLAST BABY URINE COLLECTORS received FDA 510(k) clearance on 1984-01-30, under 510(k) number K833570.

Who is the listed applicant for COLOPLAST BABY URINE COLLECTORS?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLOPLAST BABY URINE COLLECTORS?

The FDA product code for COLOPLAST BABY URINE COLLECTORS is KNX.

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Other records listing Coloplast A/S as applicant

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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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