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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 the device name listed in this FDA 510(k) record. The listed applicant is Insight Medbotics, Inc.. It received FDA 510(k) clearance on 2023-07-20 under 510(k) 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. The listed applicant is Insight Medbotics, Inc.. The 510(k) number is K223484.

When did IGAR System (1001.A) receive FDA 510(k) clearance?

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

Who is the listed applicant for IGAR System (1001.A)?

The FDA 510(k) record lists Insight Medbotics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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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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