PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY— 510(k) K870420

Unknown

North Coast Medi-Tek

FDA 510(k) clearance K870420 for PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY, Unknown on 1987-04-14. Applicant: North Coast Medi-Tek.

Clearance details

Applicant: North Coast Medi-Tek
Product code: Code GBZ
Advisory panel: General, Plastic Surgery
Date received: 1987-02-03
Decision date: 1987-04-14
Decision: Unknown
Clearance type: Traditional
Location: Mentor, OH, US

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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.