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FDA 510(k)

Ensizor Monopolar Endoscopic Scissors

K-Number: K180134 · 2018-06-29

ApplicantSlater Endoscopy, LLC
Decision Date2018-06-29
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ensizor Monopolar Endoscopic Scissors is a medical device manufactured by Slater Endoscopy, LLC. It received FDA 510(k) clearance on 2018-06-29 under approval number K180134. 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 Ensizor Monopolar Endoscopic Scissors?

Ensizor Monopolar Endoscopic Scissors is a medical device that received FDA 510(k) clearance on 2018-06-29. It is manufactured by Slater Endoscopy, LLC. The 510(k) number is K180134.

When was Ensizor Monopolar Endoscopic Scissors approved by the FDA?

Ensizor Monopolar Endoscopic Scissors received FDA 510(k) clearance on 2018-06-29, under approval number K180134.

What company makes Ensizor Monopolar Endoscopic Scissors?

Ensizor Monopolar Endoscopic Scissors is manufactured by Slater Endoscopy, LLC.

What is the FDA product code for Ensizor Monopolar Endoscopic Scissors?

The FDA product code for Ensizor Monopolar Endoscopic Scissors is KGE.

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Related Devices (Code: KGE)

K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc. K160625Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. K171916Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp. K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. K180018Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd.

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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