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

Name: FDA 510(k) clearance K133757
Creator: U.S. Food and Drug Administration
Published: 2014-02-04

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. Device class: 2.

Clearance details

Applicant: Parcus Medical, LLC
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2013-12-11
Decision date: 2014-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

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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.