FDA 510(k)

SPINAUT-E, SPINAUT-I

K-Number: K150789 · 2016-03-01

Decision Date2016-03-01

Product CodeBSO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SPINAUT-E, SPINAUT-I is a medical device manufactured by Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2016-03-01 under approval number K150789. 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 SPINAUT-E, SPINAUT-I?

SPINAUT-E, SPINAUT-I is a medical device that received FDA 510(k) clearance on 2016-03-01. It is manufactured by Imedicom Co., Ltd.. The 510(k) number is K150789.

When was SPINAUT-E, SPINAUT-I approved by the FDA?

SPINAUT-E, SPINAUT-I received FDA 510(k) clearance on 2016-03-01, under approval number K150789.

What company makes SPINAUT-E, SPINAUT-I?

SPINAUT-E, SPINAUT-I is manufactured by Imedicom Co., Ltd..

What is the FDA product code for SPINAUT-E, SPINAUT-I?

The FDA product code for SPINAUT-E, SPINAUT-I is BSO.

Other Devices by Imedicom Co., Ltd.

K153296MEDINAUT Kyphoplasty System K150915SPINAUT-P K151268SPINAUT-V, SPINAUT-S, SPINAUT-I K173541EPINAUT 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. K171584B. Braun Tear-Away Introducer NeedleB.Braun Medical, Inc. K171193Certa CatheterFerrosan Medical Devices Sp. Z.O.O.

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.