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FDA 510(k)

KWIK-FLO URINAL SYSTEM

K-Number: K781422 · 1978-09-07

ApplicantThe Grace Mfg. Co.
Decision Date1978-09-07
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KWIK-FLO URINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Grace Mfg. Co.. It received FDA 510(k) clearance on 1978-09-07 under 510(k) number K781422. 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 KWIK-FLO URINAL SYSTEM?

KWIK-FLO URINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1978-09-07. The listed applicant is The Grace Mfg. Co.. The 510(k) number is K781422.

When did KWIK-FLO URINAL SYSTEM receive FDA 510(k) clearance?

KWIK-FLO URINAL SYSTEM received FDA 510(k) clearance on 1978-09-07, under 510(k) number K781422.

Who is the listed applicant for KWIK-FLO URINAL SYSTEM?

The FDA 510(k) record lists The Grace Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KWIK-FLO URINAL SYSTEM?

The FDA product code for KWIK-FLO URINAL SYSTEM 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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