Panels › General, Plastic Surgery › Product code NUJ · Class 2
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Regulation 878.4400
0510(k)s in 12 months (37 all time)
11recalls in 12 months (20 all time)
20recalls that name a 510(k)
Top companies in NUJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Medline Industries, LP | 0 | 11 |
| Sterilmed, Inc. | 7 | 3 |
| Stryker Sustainability Solutions | 7 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 6 |
| Surgical Instrument Service and Savings, Inc. | 4 | 0 |
| Renovo, Inc. | 3 | 0 |
| Suretek Medical | 3 | 0 |
| Ascent Healthcare Solutions | 2 | 0 |
| Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2 | 0 |
| Surgical Instrument Services and Savings, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2024 | K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) Surgical Instrument Service and Savings, Inc. | NUJ |
| Mar 28, 2023 | K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) Stryker Sustainability Solutions | NUJ |
| May 13, 2022 | K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) Stryker Sustainability Solutions | NUJ |
| Apr 7, 2022 | K211203 | Green OR Reprocessed Aquamantys Bipolar Sealer Green Or, LLC | NUJ |
| Oct 22, 2019 | K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter Vein 360, LLC | NUJ |
| Oct 31, 2018 | K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider Surgical Instrument Service and Savings Inc.(Dba Medline Ren | NUJ |
| Apr 23, 2018 | K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider Stryker Sustainability Solutions | NUJ |
| Apr 20, 2018 | K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider Stryker Sustainability Solutions | NUJ |
| Mar 27, 2018 | K173214 | NES Reprocessed RF Stylet (RFS) Northeast Scientific, Inc. (Nes) | NUJ |
| Mar 19, 2018 | K173740 | Reprocessed DePuy Mitek Ablation Wand Renovo, Inc. | NUJ |
| Mar 5, 2018 | K173741 | Reprocessed ArthoCare Ablation Wand Renovo, Inc. | NUJ |
| Feb 21, 2018 | K172647 | Reprocessed ArthroCare ENT Coblator Renovo, Inc. | NUJ |
| Oct 18, 2017 | K172608 | Medline ReNewal Reprocessed Stryker SERF AS Energy Probes Surgical Instrument Service and Savings, Inc. | NUJ |
| Jun 23, 2017 | K171324 | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics Surgical Instrument Service and Savings, Inc. | NUJ |
| May 1, 2017 | K162751 | Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider Surgical Instrument Services and Savings, Inc. | NUJ |
| Sep 20, 2016 | K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Te Sterilmed, Inc. | NUJ |
| Jul 20, 2016 | K160333 | Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider Surgical Instrument Service and Savings, Inc. | NUJ |
| May 2, 2016 | K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider Surgical Instrument Service and Savings Inc.(Dba Medline Ren | NUJ |
| Jan 15, 2016 | K152134 | Reprocessed Vessel Sealer Sterilmed, Inc. | NUJ |
| Jan 6, 2016 | K152313 | Medline ReNewal Reprocessed Endopath Endoscopic Instruments Surgical Instrument Services and Savings, Inc. | NUJ |
| Jun 25, 2015 | K150538 | Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider Stryker Sustainability Solutions | NUJ |
| Feb 23, 2015 | K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider Sterilmed, Inc. | NUJ |
| Apr 10, 2014 | K133578 | REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER Stryker Sustainability Solutions | NUJ |
| Aug 29, 2013 | K131614 | REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM Covidien | NUJ |
| Jan 25, 2013 | K123096 | REPROCESSED VESSEL SEALER Sterilmed, Inc. | NUJ |
| Oct 5, 2012 | K120040 | REPROCESSED SURGICAL ELECTRIC INSTRUMENT Sterilmed, Inc. | NUJ |
| Aug 16, 2012 | K121855 | RESPROCESSED SERFAS ENERGY PROBE Stryker Sustainability Solutions | NUJ |
| Nov 15, 2011 | K111600 | REPROCESSED HAND ACTIVATE SEALER/DIVIDER Ascent Healthcare Solutions | NUJ |
| Jul 18, 2011 | K110189 | REPROCESSED ELECTROSURGICAL INSTRUMENT Ascent Healthcare Solutions | NUJ |
| Jul 21, 2010 | K090661 | NES REPROCESSED VARICOSE VEIN RF CATHETER Northeast Scientific, Inc. | NUJ |
| Feb 12, 2008 | K073613 | REPROCESSED SCISSOR TIPS Sterilmed, Inc. | NUJ |
| May 12, 2006 | K052690 | SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS Suretek Medical | NUJ |
| May 10, 2006 | K052695 | SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS Suretek Medical | NUJ |
| May 10, 2006 | K052692 | SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES Suretek Medical | NUJ |
| May 27, 2005 | K043198 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS Vanguard Medical Concepts, Inc. | NUJ |
| Nov 7, 2001 | K012603 | REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS Alliance Medical Corp. | NUJ |
| Nov 7, 2001 | K012598 | REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS Sterilmed, Inc. | NUJ |
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