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FDA 510(k)

URIFIX

K-Number: K813537 · 1982-01-12

ApplicantIsramed, Inc.
Decision Date1982-01-12
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URIFIX is the device name listed in this FDA 510(k) record. The listed applicant is Isramed, Inc.. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813537. 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 URIFIX?

URIFIX is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Isramed, Inc.. The 510(k) number is K813537.

When did URIFIX receive FDA 510(k) clearance?

URIFIX received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813537.

Who is the listed applicant for URIFIX?

The FDA 510(k) record lists Isramed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URIFIX?

The FDA product code for URIFIX 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 Isramed, Inc. 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.

K812018X-RAY DETECTABLE THREADK812017X-RAY DETECTABLE BAND

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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