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FDA 510(k)

SPINAUT-E, SPINAUT-I

K-Number: K150789 · 2016-03-01

ApplicantImedicom Co., Ltd.
Decision Date2016-03-01
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPINAUT-E, SPINAUT-I 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 2016-03-01 under 510(k) 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. The listed applicant is Imedicom Co., Ltd.. The 510(k) number is K150789.

When did SPINAUT-E, SPINAUT-I receive FDA 510(k) clearance?

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

Who is the listed applicant for SPINAUT-E, SPINAUT-I?

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 SPINAUT-E, SPINAUT-I?

The FDA product code for SPINAUT-E, SPINAUT-I 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 PlusK173541EPINAUTK153296MEDINAUT Kyphoplasty SystemK150915SPINAUT-PK151268SPINAUT-V, SPINAUT-S, 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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