Cleared Traditional

Sterilization Pouch/Roll

K251347 · Sterivic Medical Co., Ltd. · General Hospital

Jan 2026

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K251347 is an FDA 510(k) clearance for the Sterilization Pouch/Roll, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Sterivic Medical Co., Ltd. (Chizhou, CN). The FDA issued a Cleared decision on January 28, 2026, 273 days after receiving the submission on April 30, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K251347 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2025
Decision Date	January 28, 2026
Days to Decision	273 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF