TIGERPAW SYSTEM II— 510(k) K111064

Substantially Equivalent

Laax, Inc.

FDA 510(k) clearance K111064 for TIGERPAW SYSTEM II, Substantially Equivalent on 2011-05-18. Applicant: Laax, Inc..

Clearance details

Applicant: Laax, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2011-04-18
Decision date: 2011-05-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Orinda, CA, 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.