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FDA 510(k)

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology

K-Number: K160740 · 2016-05-06

ApplicantSurgical Instrument Service and Savings, Inc.
Decision Date2016-05-06
Product CodeNLM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology is a medical device manufactured by Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2016-05-06 under approval number K160740. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology?

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology is a medical device that received FDA 510(k) clearance on 2016-05-06. It is manufactured by Surgical Instrument Service and Savings, Inc.. The 510(k) number is K160740.

When was Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology approved by the FDA?

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology received FDA 510(k) clearance on 2016-05-06, under approval number K160740.

What company makes Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology?

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology is manufactured by Surgical Instrument Service and Savings, Inc..

What is the FDA product code for Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology?

The FDA product code for Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology is NLM.

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Related Devices (Code: NLM)

K153258Medline ReNewal Reprocessed Versaport V2 Bladeless Optical TrocarsSurgical Instrument Service and Savings (Dba Medline Renewal K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesRenovo, Inc. K172093Reprocessed Covidien TrocarRenovo, Inc. K182828Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserSurgical Instrument Service and Savings, Inc. K201511Reprocessed Endoscopic Trocars and SleevesStryker Sustainability Solutions

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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