FDA 510(k)

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology

Numéro K : K160740 · 2016-05-06

DemandeurSurgical Instrument Service and Savings, Inc.

Date de décision2016-05-06

Code produitNLM

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K160740.

When did Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology?

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

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.

Essais cliniques associés

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Dispositifs connexes (Code : NLM)

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Source officielle

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