PATIENT CONTOURED MESH (PCM)— 510(k) K062570

Substantially Equivalent

KLS-Martin L.P.

FDA 510(k) clearance K062570 for PATIENT CONTOURED MESH (PCM), Substantially Equivalent on 2006-10-31. Applicant: KLS-Martin L.P..

Clearance details

Applicant: KLS-Martin L.P.
Product code: Code GXN
Advisory panel: Neurology
Date received: 2006-08-31
Decision date: 2006-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

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Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.