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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 the device name listed in this FDA 510(k) record. The listed applicant is Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2018-08-24 under 510(k) 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. The listed applicant is Imedicom Co., Ltd.. The 510(k) number is K173541.

When did EPINAUT receive FDA 510(k) clearance?

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

Who is the listed applicant for EPINAUT?

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

What is the FDA product code for EPINAUT?

The FDA product code for EPINAUT is BSO.

Other records listing Imedicom 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.

K182287MEDINAUT PlusK153296MEDINAUT Kyphoplasty SystemK150915SPINAUT-PK151268SPINAUT-V, SPINAUT-S, SPINAUT-IK150789SPINAUT-E, SPINAUT-I

Related Devices (Code: BSO)

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.

K241410EDEN ControlCathJmt Co., Ltd.K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc.K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)Teleflex MedicalK193664SubQKath Catheter and Needle SetHk SurgicalK200624Percutaneous IntroducerEpimed International, Inc.K191470C-CAT Anaesthesia Catheter kitCimpax Aps

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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