Cleared Traditional

Self-Seal Sterilization Pouch and Roll

K251177 · Guangdong Maidi Medical Co., Ltd. · General Hospital

Dec 2025

Decision

240d

Days

Class 2

Risk

About This 510(k) Submission

K251177 is an FDA 510(k) clearance for the Self-Seal Sterilization Pouch and Roll, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Guangdong Maidi Medical Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on December 12, 2025, 240 days after receiving the submission on April 16, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K251177 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2025
Decision Date	December 12, 2025
Days to Decision	240 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF