FDA.reportPublic FDA data

510(k) K182828

Device
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
Applicant
Surgical Instrument Service And Savings Inc
510(k) number
K182828
Product code
NLM  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-15
Date received
2018-10-05
Regulation
876.1500
Classification name
Laparoscope, General & Plastic Surgery, Reprocessed
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stephanie Boyle Mays
Address
(Dba Medline Renewal) 1500 NE Hemlock Ave. Redmond OR US 97756 97756

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
K172097Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar SleevesRenovo, Inc.2017-10-06
K172093Reprocessed Covidien TrocarRenovo, Inc.2017-10-05
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