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FDA 510(k)

Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves

K-Number: K172097 · 2017-10-06

ApplicantRenovo, Inc.
Decision Date2017-10-06
Product CodeNLM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Renovo, Inc.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K172097. 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 Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves?

Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Renovo, Inc.. The 510(k) number is K172097.

When did Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves receive FDA 510(k) clearance?

Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves received FDA 510(k) clearance on 2017-10-06, under 510(k) number K172097.

Who is the listed applicant for Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves?

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

What is the FDA product code for Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves?

The FDA product code for Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves is NLM.

Other records listing Renovo, Inc. as applicant

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.

K173740Reprocessed DePuy Mitek Ablation WandK173741Reprocessed ArthoCare Ablation WandK172647Reprocessed ArthroCare ENT CoblatorK172093Reprocessed Covidien TrocarK172092Reprocessed Shavers/Burs

Related Devices (Code: NLM)

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.

K201511Reprocessed Endoscopic Trocars and SleevesStryker Sustainability SolutionsK182828Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserSurgical Instrument Service and Savings, Inc.K172093Reprocessed Covidien TrocarRenovo, Inc.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

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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