Cleared Traditional

GCI Surgical Gown

K233571 · George Courey, Inc. · General Hospital

Aug 2024

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K233571 is an FDA 510(k) clearance for the GCI Surgical Gown, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by George Courey, Inc. (Laval, CA). The FDA issued a Cleared decision on August 2, 2024, 270 days after receiving the submission on November 6, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K233571 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2023
Decision Date	August 02, 2024
Days to Decision	270 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF