Sterilization Pouch/Roll
K-Number: K251347 · 2026-01-28
ApplicantSterivic Medical Co., Ltd.
Decision Date2026-01-28
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Sterilization Pouch/Roll is a medical device manufactured by Sterivic Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-01-28 under approval number K251347. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sterilization Pouch/Roll?
Sterilization Pouch/Roll is a medical device that received FDA 510(k) clearance on 2026-01-28. It is manufactured by Sterivic Medical Co., Ltd.. The 510(k) number is K251347.
When was Sterilization Pouch/Roll approved by the FDA?
Sterilization Pouch/Roll received FDA 510(k) clearance on 2026-01-28, under approval number K251347.
What company makes Sterilization Pouch/Roll?
Sterilization Pouch/Roll is manufactured by Sterivic Medical Co., Ltd..
What is the FDA product code for Sterilization Pouch/Roll?
The FDA product code for Sterilization Pouch/Roll is FRG.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.