iSurg
K-Number: K170054 · 2017-10-02
Decision Date2017-10-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
iSurg is a medical device manufactured by Jaco, LLC Dba Macan Manufacturing and Bna Burz North America. It received FDA 510(k) clearance on 2017-10-02 under approval 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. It is manufactured by Jaco, LLC Dba Macan Manufacturing and Bna Burz North America. The 510(k) number is K170054.
When was iSurg approved by the FDA?
iSurg received FDA 510(k) clearance on 2017-10-02, under approval number K170054.
What company makes iSurg?
iSurg is manufactured by Jaco, LLC Dba Macan Manufacturing and Bna Burz North America.
What is the FDA product code for iSurg?
The FDA product code for iSurg is GEI.
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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.