NEUROSPONGE PADDIE— 510(k) K812390

Substantially Equivalent

Winn Hirsch & Assoc.

FDA 510(k) clearance K812390 for NEUROSPONGE PADDIE, Substantially Equivalent on 1981-11-24. Applicant: Winn Hirsch & Assoc..

Clearance details

Applicant: Winn Hirsch & Assoc.
Product code: Code GDY
Advisory panel: General, Plastic Surgery
Date received: 1981-08-20
Decision date: 1981-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GDY

product code GDY

Malfunction: 764
Total: 764

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.