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FDA 510(k)

URINEBAG

K-Number: K801021 · 1980-07-28

ApplicantUnovex of Denmark
Decision Date1980-07-28
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URINEBAG is the device name listed in this FDA 510(k) record. The listed applicant is Unovex of Denmark. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801021. 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 URINEBAG?

URINEBAG is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Unovex of Denmark. The 510(k) number is K801021.

When did URINEBAG receive FDA 510(k) clearance?

URINEBAG received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801021.

Who is the listed applicant for URINEBAG?

The FDA 510(k) record lists Unovex of Denmark as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URINEBAG?

The FDA product code for URINEBAG 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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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