Cleared Traditional

Sterilization Pouch and Roll

K243179 · Yichang Xinxin Paper Products Co., Ltd. · General Hospital

Jun 2025

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K243179 is an FDA 510(k) clearance for the Sterilization Pouch and Roll, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Yichang Xinxin Paper Products Co., Ltd. (Yichang City, CN). The FDA issued a Cleared decision on June 26, 2025, 269 days after receiving the submission on September 30, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K243179 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	June 26, 2025
Days to Decision	269 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF