FLASHPAK— 510(k) K113776

Substantially Equivalent

Symmetry Medical

FDA 510(k) clearance K113776 for FLASHPAK, Substantially Equivalent on 2012-08-08. Applicant: Symmetry Medical.

Clearance details

Applicant: Symmetry Medical
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2011-12-22
Decision date: 2012-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.