Atlas FDA

NUJ

37 FDA 510(k) clearances · Product code

140 daysmedian time to decision
255 days90th percentile
37clearances measured

FDA profile

Official device name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
FDA definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Adverse events (MAUDE)
2021: 47 · 2022: 31 · 2023: 27 · 2024: 92 · 2025: 38 · 2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (K232511)Surgical Instrument Service and Savings, Inc.2024-04-29
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (K230251)Stryker Sustainability Solutions2023-03-28
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (K220411)Stryker Sustainability Solutions2022-05-13
Green OR Reprocessed Aquamantys Bipolar Sealer (K211203)Green Or, LLC2022-04-07
Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (K191073)Vein 360, LLC2019-10-22
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider (K182588)Surgical Instrument Service and Savings Inc.(Dba Medline Ren2018-10-31
Reprocessed LigaSure Maryland Jaw Sealer/Divider (K180499)Stryker Sustainability Solutions2018-04-23
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (K180451)Stryker Sustainability Solutions2018-04-20
NES Reprocessed RF Stylet (RFS) (K173214)Northeast Scientific, Inc. (Nes)2018-03-27
Reprocessed DePuy Mitek Ablation Wand (K173740)Renovo, Inc.2018-03-19
Reprocessed ArthoCare Ablation Wand (K173741)Renovo, Inc.2018-03-05
Reprocessed ArthroCare ENT Coblator (K172647)Renovo, Inc.2018-02-21
Medline ReNewal Reprocessed Stryker SERF AS Energy Probes (K172608)Surgical Instrument Service and Savings, Inc.2017-10-18
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics (K171324)Surgical Instrument Service and Savings, Inc.2017-06-23
Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider (K162751)Surgical Instrument Services and Savings, Inc.2017-05-01
Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) (K161086)Sterilmed, Inc.2016-09-20
Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider (K160333)Surgical Instrument Service and Savings, Inc.2016-07-20
Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider (K153745)Surgical Instrument Service and Savings Inc.(Dba Medline Ren2016-05-02
Reprocessed Vessel Sealer (K152134)Sterilmed, Inc.2016-01-15
Medline ReNewal Reprocessed Endopath Endoscopic Instruments (K152313)Surgical Instrument Services and Savings, Inc.2016-01-06
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider (K150538)Stryker Sustainability Solutions2015-06-25
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider (K143260)Sterilmed, Inc.2015-02-23
REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER (K133578)Stryker Sustainability Solutions2014-04-10
REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM (K131614)Covidien2013-08-29
REPROCESSED VESSEL SEALER (K123096)Sterilmed, Inc.2013-01-25
REPROCESSED SURGICAL ELECTRIC INSTRUMENT (K120040)Sterilmed, Inc.2012-10-05
RESPROCESSED SERFAS ENERGY PROBE (K121855)Stryker Sustainability Solutions2012-08-16
REPROCESSED HAND ACTIVATE SEALER/DIVIDER (K111600)Ascent Healthcare Solutions2011-11-15
REPROCESSED ELECTROSURGICAL INSTRUMENT (K110189)Ascent Healthcare Solutions2011-07-18
NES REPROCESSED VARICOSE VEIN RF CATHETER (K090661)Northeast Scientific, Inc.2010-07-21
REPROCESSED SCISSOR TIPS (K073613)Sterilmed, Inc.2008-02-12
SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS (K052690)Suretek Medical2006-05-12
SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES (K052692)Suretek Medical2006-05-10
SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS (K052695)Suretek Medical2006-05-10
VANGUARD REPROCESSED ARTHROSCOPIC WANDS (K043198)Vanguard Medical Concepts, Inc.2005-05-27
REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS (K012598)Sterilmed, Inc.2001-11-07
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS (K012603)Alliance Medical Corp.2001-11-07

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Every clearance here is in the API, with alerts when new ones post.