CHIBA SKINNY NEEDLE— 510(k) K813460

Substantially Equivalent

Ocean Medical Products, Ltd.

FDA 510(k) clearance K813460 for CHIBA SKINNY NEEDLE, Substantially Equivalent on 1982-01-07. Applicant: Ocean Medical Products, Ltd..

Clearance details

Applicant: Ocean Medical Products, Ltd.
Product code: Code GAA
Advisory panel: General, Plastic Surgery
Date received: 1981-12-11
Decision date: 1982-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.