Miracu Polydioxanone (PDO) Suture and Needle (MONO)
K-Number: K251414 · 2025-10-20
ApplicantFeeltech Co., Ltd.
Decision Date2025-10-20
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Miracu Polydioxanone (PDO) Suture and Needle (MONO) is a medical device manufactured by Feeltech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-20 under approval number K251414. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Miracu Polydioxanone (PDO) Suture and Needle (MONO)?
Miracu Polydioxanone (PDO) Suture and Needle (MONO) is a medical device that received FDA 510(k) clearance on 2025-10-20. It is manufactured by Feeltech Co., Ltd.. The 510(k) number is K251414.
When was Miracu Polydioxanone (PDO) Suture and Needle (MONO) approved by the FDA?
Miracu Polydioxanone (PDO) Suture and Needle (MONO) received FDA 510(k) clearance on 2025-10-20, under approval number K251414.
What company makes Miracu Polydioxanone (PDO) Suture and Needle (MONO)?
Miracu Polydioxanone (PDO) Suture and Needle (MONO) is manufactured by Feeltech Co., Ltd..
What is the FDA product code for Miracu Polydioxanone (PDO) Suture and Needle (MONO)?
The FDA product code for Miracu Polydioxanone (PDO) Suture and Needle (MONO) is NEW.
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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.