GFS II STANDARD, GFS II LARGE, GFS MIMI— 510(k) K133757

Substantially Equivalent

Parcus Medical, LLC

FDA 510(k) clearance K133757 for GFS II STANDARD, GFS II LARGE, GFS MIMI, Substantially Equivalent on 2014-02-04. Applicant: Parcus Medical, LLC.

Clearance details

Applicant: Parcus Medical, LLC
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2013-12-11
Decision date: 2014-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Sarasota, FL, US

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.