GCI Sterilization Wrappers— 510(k) K250321

Substantially Equivalent

George Courey, Inc.

FDA 510(k) clearance K250321 for GCI Sterilization Wrappers, Substantially Equivalent on 2025-06-06. Applicant: George Courey, Inc..

Clearance details

Applicant: George Courey, Inc.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2025-02-04
Decision date: 2025-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval, CA

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.