Cleared Traditional

GCI Sterilization Wrappers

K250321 · George Courey, Inc. · General Hospital

Jun 2025

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K250321 is an FDA 510(k) clearance for the GCI Sterilization Wrappers, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by George Courey, Inc. (Laval, CA). The FDA issued a Cleared decision on June 6, 2025, 122 days after receiving the submission on February 4, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K250321 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2025
Decision Date	June 06, 2025
Days to Decision	122 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF