Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BAG, URINE

K-Number: K902417 · 1990-07-16

ApplicantGainor Medical Europe, Ltd.
Decision Date1990-07-16
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAG, URINE is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical Europe, Ltd.. It received FDA 510(k) clearance on 1990-07-16 under 510(k) number K902417. 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 BAG, URINE?

BAG, URINE is a medical device that received FDA 510(k) clearance on 1990-07-16. The listed applicant is Gainor Medical Europe, Ltd.. The 510(k) number is K902417.

When did BAG, URINE receive FDA 510(k) clearance?

BAG, URINE received FDA 510(k) clearance on 1990-07-16, under 510(k) number K902417.

Who is the listed applicant for BAG, URINE?

The FDA 510(k) record lists Gainor Medical Europe, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAG, URINE?

The FDA product code for BAG, URINE 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

Other records listing Gainor Medical Europe, Ltd. 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.

K926448I.V. ADMINISTRATION SETK931828CARELET SAFETY LANCETK931827CLEANLET, CLEANLET XL & KIDSK922441SURESEAL BANDAGEK913333I.V. PRIMING SETK902422NEEDLE, ASPIRATION & INJECTION, DISPOSABLE

View all 13 devices →

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.

↑