Cleared Traditional

Self Sealing Sterilization Pouches

K243721 · Wellmed Dental Medical Supply Co., Ltd. · General Hospital

Apr 2025

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K243721 is an FDA 510(k) clearance for the Self Sealing Sterilization Pouches, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Wellmed Dental Medical Supply Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 25, 2025, 143 days after receiving the submission on December 3, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K243721 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 2024
Decision Date	April 25, 2025
Days to Decision	143 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement