510(k) K243179

Sterilization Pouch and Roll by Yichang Xinxin Paper Products Co., Ltd. — Product Code FRG

K243179 is an FDA 510(k) premarket notification submitted by Yichang Xinxin Paper Products Co., Ltd. for the device "Sterilization Pouch and Roll". The FDA issued a decision of Substantially Equivalent on June 26, 2025. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type