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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 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.

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. 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.

Other records listing Surgical Instrument Service and Savings, 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.

K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerK252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic CatheterK250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic CatheterK250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

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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.K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesRenovo, Inc.K172093Reprocessed Covidien TrocarRenovo, Inc.K153258Medline ReNewal Reprocessed Versaport V2 Bladeless Optical TrocarsSurgical Instrument Service and Savings (Dba Medline Renewal

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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