FDA 510(k)

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars

Номер K: K153258 · 2016-04-05

ЗаявительSurgical Instrument Service and Savings (Dba Medline Renewal

Дата решения2016-04-05

Код продуктаNLM

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings (Dba Medline Renewal. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K153258. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars?

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Surgical Instrument Service and Savings (Dba Medline Renewal. The 510(k) number is K153258.

When did Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars received FDA 510(k) clearance on 2016-04-05, under 510(k) number K153258.

Who is the listed applicant for Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars?

The FDA 510(k) record lists Surgical Instrument Service and Savings (Dba Medline Renewal as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars?

The FDA product code for Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars is NLM.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: NLM)

K201511Reprocessed Endoscopic Trocars and SleevesStryker Sustainability Solutions K182828Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserSurgical Instrument Service and Savings, Inc.K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesRenovo, Inc.K172093Reprocessed Covidien TrocarRenovo, Inc.K160740Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW TechnologySurgical Instrument Service and Savings, Inc.

Официальный источник

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