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)

GABRIEL URETERAL ILLUMINATOR SYSTEM II

K-Number: K945088 · 1995-02-07

ApplicantGabriel Medical, Inc.
Decision Date1995-02-07
Product CodeFCS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GABRIEL URETERAL ILLUMINATOR SYSTEM II 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 1995-02-07 under 510(k) number K945088. 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 II?

GABRIEL URETERAL ILLUMINATOR SYSTEM II is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is Gabriel Medical, Inc.. The 510(k) number is K945088.

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

GABRIEL URETERAL ILLUMINATOR SYSTEM II received FDA 510(k) clearance on 1995-02-07, under 510(k) number K945088.

Who is the listed applicant for GABRIEL URETERAL ILLUMINATOR SYSTEM II?

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 II?

The FDA product code for GABRIEL URETERAL ILLUMINATOR SYSTEM II 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 KITK945297INFRA VISION IMAGING SYSTEMK940019GABRIEL URETERAL ILLUMINATOR 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.K941506URETERAL ILLUMINATORApple Medical Corp.K940019GABRIEL URETERAL ILLUMINATOR SYSTEMGabriel Medical, Inc.K923436ILLUMINATED URETERAL CATHETERCook Urological, 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.

↑