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FDA 510(k)

IGAR System (1001.A)

K-Number: K223484 · 2023-07-20

ApplicantInsight Medbotics, Inc.
Decision Date2023-07-20
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IGAR System (1001.A) is a medical device manufactured by Insight Medbotics, Inc.. It received FDA 510(k) clearance on 2023-07-20 under approval number K223484. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGAR System (1001.A)?

IGAR System (1001.A) is a medical device that received FDA 510(k) clearance on 2023-07-20. It is manufactured by Insight Medbotics, Inc.. The 510(k) number is K223484.

When was IGAR System (1001.A) approved by the FDA?

IGAR System (1001.A) received FDA 510(k) clearance on 2023-07-20, under approval number K223484.

What company makes IGAR System (1001.A)?

IGAR System (1001.A) is manufactured by Insight Medbotics, Inc..

What is the FDA product code for IGAR System (1001.A)?

The FDA product code for IGAR System (1001.A) is MOS.

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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.

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