Cleared Traditional

Safe Secure Sterilization Pouches and Rolls

K242839 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · General Hospital

Oct 2024

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K242839 is an FDA 510(k) clearance for the Safe Secure Sterilization Pouches and Rolls, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2024, 27 days after receiving the submission on September 19, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K242839 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2024
Decision Date	October 16, 2024
Days to Decision	27 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF