Self-Seal Sterilization Pouch and Roll
K-Number: K251177 · 2025-12-12
ApplicantGuangdong Maidi Medical Co., Ltd.
Decision Date2025-12-12
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Self-Seal Sterilization Pouch and Roll is a medical device manufactured by Guangdong Maidi Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-12-12 under approval number K251177. 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 Self-Seal Sterilization Pouch and Roll?
Self-Seal Sterilization Pouch and Roll is a medical device that received FDA 510(k) clearance on 2025-12-12. It is manufactured by Guangdong Maidi Medical Co., Ltd.. The 510(k) number is K251177.
When was Self-Seal Sterilization Pouch and Roll approved by the FDA?
Self-Seal Sterilization Pouch and Roll received FDA 510(k) clearance on 2025-12-12, under approval number K251177.
What company makes Self-Seal Sterilization Pouch and Roll?
Self-Seal Sterilization Pouch and Roll is manufactured by Guangdong Maidi Medical Co., Ltd..
What is the FDA product code for Self-Seal Sterilization Pouch and Roll?
The FDA product code for Self-Seal Sterilization Pouch and 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.