STERILE DISSECTOR SPONGES-X-RAY DETECT— 510(k) K812707

Substantially Equivalent

Medspec Corp.

FDA 510(k) clearance K812707 for STERILE DISSECTOR SPONGES-X-RAY DETECT, Substantially Equivalent on 1981-11-02. Applicant: Medspec Corp..

Clearance details

Applicant: Medspec Corp.
Product code: Code GDY
Advisory panel: General, Plastic Surgery
Date received: 1981-09-24
Decision date: 1981-11-02
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.