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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 the device name listed in this FDA 510(k) record. The listed applicant is Slater Endoscopy, LLC. It received FDA 510(k) clearance on 2018-06-29 under 510(k) 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. The listed applicant is Slater Endoscopy, LLC. The 510(k) number is K180134.

When did Ensizor Monopolar Endoscopic Scissors receive FDA 510(k) clearance?

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

Who is the listed applicant for Ensizor Monopolar Endoscopic Scissors?

The FDA 510(k) record lists Slater Endoscopy, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: KGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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