TITANIUM MESH— 510(k) K903485

Substantially Equivalent

Ruggles Corp.

FDA 510(k) clearance K903485 for TITANIUM MESH, Substantially Equivalent on 1991-02-21. Applicant: Ruggles Corp..

Clearance details

Applicant: Ruggles Corp.
Product code: Code GWO
Advisory panel: Neurology
Date received: 1990-07-31
Decision date: 1991-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: No. Quincy, MA, US

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Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.