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FDA 510(k)

Reprocessed Endoscopic Trocars and Sleeves

K-Number: K201511 · 2020-07-31

ApplicantStryker Sustainability Solutions
Decision Date2020-07-31
Product CodeNLM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Reprocessed Endoscopic Trocars and Sleeves is a medical device manufactured by Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2020-07-31 under approval number K201511. 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 Reprocessed Endoscopic Trocars and Sleeves?

Reprocessed Endoscopic Trocars and Sleeves is a medical device that received FDA 510(k) clearance on 2020-07-31. It is manufactured by Stryker Sustainability Solutions. The 510(k) number is K201511.

When was Reprocessed Endoscopic Trocars and Sleeves approved by the FDA?

Reprocessed Endoscopic Trocars and Sleeves received FDA 510(k) clearance on 2020-07-31, under approval number K201511.

What company makes Reprocessed Endoscopic Trocars and Sleeves?

Reprocessed Endoscopic Trocars and Sleeves is manufactured by Stryker Sustainability Solutions.

What is the FDA product code for Reprocessed Endoscopic Trocars and Sleeves?

The FDA product code for Reprocessed Endoscopic Trocars and Sleeves is NLM.

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Related Devices (Code: NLM)

K160740Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW TechnologySurgical Instrument Service and Savings, Inc. 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.

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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