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FDA 510(k)

ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165

K-Number: K090583 · 2009-06-26

ApplicantApollo Endosurgery, Inc.
Decision Date2009-06-26
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery, Inc.. It received FDA 510(k) clearance on 2009-06-26 under 510(k) number K090583. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165?

ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 is a medical device that received FDA 510(k) clearance on 2009-06-26. The listed applicant is Apollo Endosurgery, Inc.. The 510(k) number is K090583.

When did ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 receive FDA 510(k) clearance?

ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 received FDA 510(k) clearance on 2009-06-26, under 510(k) number K090583.

Who is the listed applicant for ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165?

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

What is the FDA product code for ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165?

The FDA product code for ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 is KGE.

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Other records listing Apollo Endosurgery, Inc. as applicant

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Related Devices (Code: KGE)

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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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