GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN— 510(k) K864193

Substantially Equivalent

Gaw, Inc.

FDA 510(k) clearance K864193 for GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN, Substantially Equivalent on 1986-11-17. Applicant: Gaw, Inc..

Clearance details

Applicant: Gaw, Inc.
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1986-10-27
Decision date: 1986-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

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Adverse events under product code GDM

product code GDM

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.