CLARUS CHOLANGIOGRAM CATHETER KIT— 510(k) K925742

Name: FDA 510(k) clearance K925742
Creator: U.S. Food and Drug Administration
Published: 1993-06-01

Unknown

Clarus Medical Systems, Inc.

FDA 510(k) clearance K925742 for CLARUS CHOLANGIOGRAM CATHETER KIT, Unknown on 1993-06-01. Applicant: Clarus Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Clarus Medical Systems, Inc.
Product code: Code GBZ
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1992-11-13
Decision date: 1993-06-01
Decision: Unknown
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE1993-07-13

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K971455 — CLARUS MODEL 5197 SIGHTLITE1997-05-20
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Adverse events under product code GBZ

product code GBZ

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.