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FDA 510(k)

iSurg

K-Number: K170054 · 2017-10-02

ApplicantJaco, LLC Dba Macan Manufacturing and Bna Burz North America
Decision Date2017-10-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

iSurg is the device name listed in this FDA 510(k) record. The listed applicant is Jaco, LLC Dba Macan Manufacturing and Bna Burz North America. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K170054. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iSurg?

iSurg is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Jaco, LLC Dba Macan Manufacturing and Bna Burz North America. The 510(k) number is K170054.

When did iSurg receive FDA 510(k) clearance?

iSurg received FDA 510(k) clearance on 2017-10-02, under 510(k) number K170054.

Who is the listed applicant for iSurg?

The FDA 510(k) record lists Jaco, LLC Dba Macan Manufacturing and Bna Burz North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iSurg?

The FDA product code for iSurg is GEI.

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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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