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510(k) K172093

Device
Reprocessed Covidien Trocar
Applicant
Renovo, Inc.
510(k) number
K172093
Product code
NLM  
Decision
Substantially Equivalent (SESE)
Decision date
2017-10-05
Date received
2017-07-11
Regulation
876.1500
Classification name
Laparoscope, General & Plastic Surgery, Reprocessed
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mark K. Wells
Address
340 SW Columbia St., Bend OR US 97702 97702

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NLM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201511Reprocessed Endoscopic Trocars and SleevesStryker Sustainability Solutions2020-07-31
K182828Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture PasserSurgical Instrument Service and Savings, Inc.2019-04-15
K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesRenovo, Inc.2017-10-06
K160740Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW TechnologySurgical Instrument Service and Savings, Inc.2016-05-06
K153258Medline ReNewal Reprocessed Versaport V2 Bladeless Optical TrocarsSurgical Instrument Service and Savings (Dba Medline Renewal2016-04-05
K133414REPROCESSED CLOSURE SYSTEMSterilmed, Inc.2014-01-22
K132629REPROCESSED DILATING TIP TROCARSStryker Sustainability Solutions2013-12-31
K121240REPROCESSED ENDOSCOPIC TROCARSSterilmed, Inc.2012-06-11
K111002REPROCESSED ENDOSCOPIC TROCARSSterilmed, Inc.2011-07-18
K100080REPROCESSED TROCARS, MODEL B5LT AND CB5LTAscent Healthcare Solutions2010-03-19
K063788REPROCESSED ENDOSCOPIC TROCARS AND CANNULASAscent Healthcare Solutions2007-10-15
K070059REPROCESSED TROCARSAscent Healthcare Solutions2007-10-02
K060676NES REPROCESSED ENDOSCOPIC TROCARNortheast Scientific, Inc.2007-09-07
K062497REPROCESSED TROCARSAscent Healthcare Solutions2007-01-31
K053585VANGUARD REPROCESSED SUTURE PASSERAscent Healthcare Solutions2006-10-11

Legacy Summary#

summary

FDA Review#

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