Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Miracu

K-Number: K172602 · 2018-11-14

ApplicantFeeltech Co., Ltd.
Decision Date2018-11-14
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Miracu 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 2018-11-14 under 510(k) number K172602. 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?

Miracu is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Feeltech Co., Ltd.. The 510(k) number is K172602.

When did Miracu receive FDA 510(k) clearance?

Miracu received FDA 510(k) clearance on 2018-11-14, under 510(k) number K172602.

Who is the listed applicant for Miracu?

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?

The FDA product code for Miracu is NEW.

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.

K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)K250107V-soft Line™ Barbed Surgical Suture (Various)K213010FEELject LDV (Low dead volume) syringe

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.K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.K250107V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.

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.

↑