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FDA 510(k)

GABRIEL URETERAL ILLUMINATOR SYSTEM

K-Number: K940019 · 1994-05-02

ApplicantGabriel Medical, Inc.
Decision Date1994-05-02
Product CodeFCS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GABRIEL URETERAL ILLUMINATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gabriel Medical, Inc.. It received FDA 510(k) clearance on 1994-05-02 under 510(k) number K940019. The device is classified under product code FCS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GABRIEL URETERAL ILLUMINATOR SYSTEM?

GABRIEL URETERAL ILLUMINATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1994-05-02. The listed applicant is Gabriel Medical, Inc.. The 510(k) number is K940019.

When did GABRIEL URETERAL ILLUMINATOR SYSTEM receive FDA 510(k) clearance?

GABRIEL URETERAL ILLUMINATOR SYSTEM received FDA 510(k) clearance on 1994-05-02, under 510(k) number K940019.

Who is the listed applicant for GABRIEL URETERAL ILLUMINATOR SYSTEM?

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

What is the FDA product code for GABRIEL URETERAL ILLUMINATOR SYSTEM?

The FDA product code for GABRIEL URETERAL ILLUMINATOR SYSTEM is FCS.

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 Gabriel Medical, 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.

K960173INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KITK945088GABRIEL URETERAL ILLUMINATOR SYSTEM IIK945297INFRA VISION IMAGING SYSTEMK901385GABRIEL MEDICAL CLS THERMAL RECORDER

Related Devices (Code: FCS)

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.

K061548STRYKER URETERAL ILLUMINATION SYSTEM IVStryker Corp.K982542STRYKER URETERAL ILLUMINATOR SYSTEM IIIStryker EndoscopyK943801URIGLOW TRANSILLUMINATING URETERIC STENT MODELRocket of London, Ltd.K945088GABRIEL URETERAL ILLUMINATOR SYSTEM IIGabriel Medical, Inc.K941506URETERAL ILLUMINATORApple Medical Corp.K923436ILLUMINATED URETERAL CATHETERCook Urological, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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