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FDA 510(k)

EPINAUT

K-Number: K173541 · 2018-08-24

ApplicantImedicom Co., Ltd.
Decision Date2018-08-24
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EPINAUT is a medical device manufactured by Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2018-08-24 under approval number K173541. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPINAUT?

EPINAUT is a medical device that received FDA 510(k) clearance on 2018-08-24. It is manufactured by Imedicom Co., Ltd.. The 510(k) number is K173541.

When was EPINAUT approved by the FDA?

EPINAUT received FDA 510(k) clearance on 2018-08-24, under approval number K173541.

What company makes EPINAUT?

EPINAUT is manufactured by Imedicom Co., Ltd..

What is the FDA product code for EPINAUT?

The FDA product code for EPINAUT is BSO.

Other Devices by Imedicom Co., Ltd.

K153296MEDINAUT Kyphoplasty System K150915SPINAUT-P K151268SPINAUT-V, SPINAUT-S, SPINAUT-I K150789SPINAUT-E, SPINAUT-I K182287MEDINAUT Plus

Related Devices (Code: BSO)

K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitHalyard Health K153297Perifix and Contiplex CatheterB.Braun Medical, Inc. K152952E-CathPAJUNK GmbH Medizintechnologie K150731Medline Epidural CatheterMedline Industries, Inc. K150789SPINAUT-E, SPINAUT-IImedicom Co., Ltd. K171584B. Braun Tear-Away Introducer NeedleB.Braun Medical, Inc.

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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