HEM-O-LOK -- MODIFICATION— 510(k) K922186

Substantially Equivalent

Linvatec Corp.

FDA 510(k) clearance K922186 for HEM-O-LOK -- MODIFICATION, Substantially Equivalent on 1992-08-06. Applicant: Linvatec Corp..

Clearance details

Applicant: Linvatec Corp.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 1992-02-27
Decision date: 1992-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pa, NC, US

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.