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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Feeltech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-20 under 510(k) 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. The listed applicant is Feeltech Co., Ltd.. The 510(k) number is K251414.

When did Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) receive FDA 510(k) clearance?

Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) received FDA 510(k) clearance on 2025-10-20, under 510(k) number K251414.

Who is the listed applicant for Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)?

The FDA 510(k) record lists Feeltech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06404372To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) SutureCOMPLETED

Other records listing Feeltech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250107V-soft Line™ Barbed Surgical Suture (Various)K213010FEELject LDV (Low dead volume) syringeK172602Miracu

Related Devices (Code: NEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless SutureM/s. Meril Endo Surgery Private Limited.

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.

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