FDA.reportPublic FDA data

510(k) K232511

Device
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
Applicant
Surgical Instrument Service and Savings, Inc.
510(k) number
K232511
Product code
NUJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-29
Date received
2023-08-18
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Medical specialty
General, Plastic Surgery
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 NUJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230251Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions2023-03-28
K220411Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)Stryker Sustainability Solutions2022-05-13
K211203Green OR Reprocessed Aquamantys Bipolar SealerGreen Or, LLC2022-04-07
K191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLC2019-10-22
K182588Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren2018-10-31
K180499Reprocessed LigaSure Maryland Jaw Sealer/DividerStryker Sustainability Solutions2018-04-23
K180451Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/DividerStryker Sustainability Solutions2018-04-20
K173214NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)2018-03-27
K173740Reprocessed DePuy Mitek Ablation WandRenovo, Inc.2018-03-19
K173741Reprocessed ArthoCare Ablation WandRenovo, Inc.2018-03-05
K172647Reprocessed ArthroCare ENT CoblatorRenovo, Inc.2018-02-21
K172608Medline ReNewal Reprocessed Stryker SERF AS Energy ProbesSurgical Instrument Service and Savings, Inc.2017-10-18
K171324Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew DyonicsSurgical Instrument Service and Savings, Inc.2017-06-23
K162751Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/DividerSurgical Instrument Services and Savings, Inc.2017-05-01
K161086Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)Sterilmed, Inc.2016-09-20