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FDA 510(k)

COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM

K-Number: K844684 · 1985-01-08

ApplicantColoplast A/S
Decision Date1985-01-08
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM 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 1985-01-08 under 510(k) number K844684. 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 URO 2002 NIGHT DRAINAGE SYSTEM?

COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Coloplast A/S. The 510(k) number is K844684.

When did COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM receive FDA 510(k) clearance?

COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM received FDA 510(k) clearance on 1985-01-08, under 510(k) number K844684.

Who is the listed applicant for COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM?

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 URO 2002 NIGHT DRAINAGE SYSTEM?

The FDA product code for COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM 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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