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FDA 510(k)

AED MONOPOLAR LAP ACCESSORIES

K-Number: K081503 · 2008-09-25

ApplicantNational Advanced Endoscopy Devices, Inc.
Decision Date2008-09-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AED MONOPOLAR LAP ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is National Advanced Endoscopy Devices, Inc.. It received FDA 510(k) clearance on 2008-09-25 under 510(k) number K081503. 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 AED MONOPOLAR LAP ACCESSORIES?

AED MONOPOLAR LAP ACCESSORIES is a medical device that received FDA 510(k) clearance on 2008-09-25. The listed applicant is National Advanced Endoscopy Devices, Inc.. The 510(k) number is K081503.

When did AED MONOPOLAR LAP ACCESSORIES receive FDA 510(k) clearance?

AED MONOPOLAR LAP ACCESSORIES received FDA 510(k) clearance on 2008-09-25, under 510(k) number K081503.

Who is the listed applicant for AED MONOPOLAR LAP ACCESSORIES?

The FDA 510(k) record lists National Advanced Endoscopy Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AED MONOPOLAR LAP ACCESSORIES?

The FDA product code for AED MONOPOLAR LAP ACCESSORIES is GEI.

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Other records listing National Advanced Endoscopy Devices, Inc. as applicant

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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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