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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 a medical device manufactured by Feeltech Co., Ltd.. It received FDA 510(k) clearance on 2018-11-14 under approval 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. It is manufactured by Feeltech Co., Ltd.. The 510(k) number is K172602.

When was Miracu approved by the FDA?

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

What company makes Miracu?

Miracu is manufactured by Feeltech Co., Ltd..

What is the FDA product code for Miracu?

The FDA product code for Miracu is NEW.

Other Devices by Feeltech Co., Ltd.

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

Related Devices (Code: NEW)

K160705Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. Jacobs Medical, Inc. K160761DW-1CDongwon Medical Co., Ltd. K150553FilblocAssut Europe K161737RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX UndyedMyco Medical K181582DemeTECH DemeDIOX absorbable surgical sutureDemetech Corporation K162366Omega VLOv World 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.

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