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FDA 510(k)

JustRight Surgical Vessel Sealing System

K-Number: K160602 · 2016-06-23

ApplicantJustright Surgical
Decision Date2016-06-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JustRight Surgical Vessel Sealing System is the device name listed in this FDA 510(k) record. The listed applicant is Justright Surgical. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K160602. 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 JustRight Surgical Vessel Sealing System?

JustRight Surgical Vessel Sealing System is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Justright Surgical. The 510(k) number is K160602.

When did JustRight Surgical Vessel Sealing System receive FDA 510(k) clearance?

JustRight Surgical Vessel Sealing System received FDA 510(k) clearance on 2016-06-23, under 510(k) number K160602.

Who is the listed applicant for JustRight Surgical Vessel Sealing System?

The FDA 510(k) record lists Justright Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JustRight Surgical Vessel Sealing System?

The FDA product code for JustRight Surgical Vessel Sealing System 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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