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FDA 510(k)

LAGIS ENDOSCOPIC INSTRUMENTS

K-Number: K090309 · 2009-08-28

ApplicantLagis Enterprises Co, Ltd.
Decision Date2009-08-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAGIS ENDOSCOPIC INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Lagis Enterprises Co, Ltd.. It received FDA 510(k) clearance on 2009-08-28 under 510(k) number K090309. 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 LAGIS ENDOSCOPIC INSTRUMENTS?

LAGIS ENDOSCOPIC INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2009-08-28. The listed applicant is Lagis Enterprises Co, Ltd.. The 510(k) number is K090309.

When did LAGIS ENDOSCOPIC INSTRUMENTS receive FDA 510(k) clearance?

LAGIS ENDOSCOPIC INSTRUMENTS received FDA 510(k) clearance on 2009-08-28, under 510(k) number K090309.

Who is the listed applicant for LAGIS ENDOSCOPIC INSTRUMENTS?

The FDA 510(k) record lists Lagis Enterprises Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAGIS ENDOSCOPIC INSTRUMENTS?

The FDA product code for LAGIS ENDOSCOPIC INSTRUMENTS 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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