NEWMAN CANNULAE SYSTEM (NCS)— 510(k) K862936

Substantially Equivalent for Some Indications

Byron Medical

FDA 510(k) clearance K862936 for NEWMAN CANNULAE SYSTEM (NCS), Substantially Equivalent for Some Indications on 1986-08-14. Applicant: Byron Medical.

Clearance details

Applicant: Byron Medical
Product code: Code GEA
Advisory panel: General, Plastic Surgery
Date received: 1986-08-04
Decision date: 1986-08-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Tucson, AZ, US

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Adverse events under product code GEA

product code GEA

Malfunction: 587
Total: 587

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.