PERI-GUARD PERICARDIAL PATCH-HERNIA— 510(k) K833021

Substantially Equivalent

Genetic

FDA 510(k) clearance K833021 for PERI-GUARD PERICARDIAL PATCH-HERNIA, Substantially Equivalent on 1983-12-26. Applicant: Genetic.

Clearance details

Applicant: Genetic
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 1983-09-06
Decision date: 1983-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.