Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NUJ · Predicate Candidate Screening
37 FDA 510(k) clearances under this product code; the 50 most recent screened below.
140 daysmedian FDA review time
255 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-c | Surgical Instrument Service and Savings, Inc. | 2024-04-29 | 255 | 1 |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider | Stryker Sustainability Solutions | 2023-03-28 | 57 | 0 |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider | Stryker Sustainability Solutions | 2022-05-13 | 88 | 0 |
| K211203 | Green OR Reprocessed Aquamantys Bipolar Sealer | Green Or, LLC | 2022-04-07 | 350 | 0 |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter | Vein 360, LLC | 2019-10-22 | 183 | 0 |
| K182588 | Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Div | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2018-10-31 | 41 | 5 |
| K180499 | Reprocessed LigaSure Maryland Jaw Sealer/Divider | Stryker Sustainability Solutions | 2018-04-23 | 56 | 0 |
| K180451 | Reprocessed LigaSure Impact without Nano-coating Large Jaw, | Stryker Sustainability Solutions | 2018-04-20 | 59 | 0 |
| K173214 | NES Reprocessed RF Stylet (RFS) | Northeast Scientific, Inc. (Nes) | 2018-03-27 | 176 | 0 |
| K173740 | Reprocessed DePuy Mitek Ablation Wand | Renovo, Inc. | 2018-03-19 | 102 | 0 |
| K173741 | Reprocessed ArthoCare Ablation Wand | Renovo, Inc. | 2018-03-05 | 88 | 0 |
| K172647 | Reprocessed ArthroCare ENT Coblator | Renovo, Inc. | 2018-02-21 | 173 | 0 |
| K172608 | Medline ReNewal Reprocessed Stryker SERF AS Energy Probes | Surgical Instrument Service and Savings, Inc. | 2017-10-18 | 48 | 0 |
| K171324 | Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith | Surgical Instrument Service and Savings, Inc. | 2017-06-23 | 49 | 0 |
| K162751 | Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open | Surgical Instrument Services and Savings, Inc. | 2017-05-01 | 213 | 1 |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology | Sterilmed, Inc. | 2016-09-20 | 155 | 0 |
| K160333 | Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/D | Surgical Instrument Service and Savings, Inc. | 2016-07-20 | 163 | 6 |
| K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divi | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2016-05-02 | 125 | 4 |
| K152134 | Reprocessed Vessel Sealer | Sterilmed, Inc. | 2016-01-15 | 168 | 0 |
| K152313 | Medline ReNewal Reprocessed Endopath Endoscopic Instruments | Surgical Instrument Services and Savings, Inc. | 2016-01-06 | 142 | 0 |
| K150538 | Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer | Stryker Sustainability Solutions | 2015-06-25 | 114 | 0 |
| K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic S | Sterilmed, Inc. | 2015-02-23 | 102 | 0 |
| K133578 | REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER | Stryker Sustainability Solutions | 2014-04-10 | 140 | 0 |
| K131614 | REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROC | Covidien | 2013-08-29 | 87 | 0 |
| K123096 | REPROCESSED VESSEL SEALER | Sterilmed, Inc. | 2013-01-25 | 115 | 0 |
| K120040 | REPROCESSED SURGICAL ELECTRIC INSTRUMENT | Sterilmed, Inc. | 2012-10-05 | 274 | 0 |
| K121855 | RESPROCESSED SERFAS ENERGY PROBE | Stryker Sustainability Solutions | 2012-08-16 | 52 | 0 |
| K111600 | REPROCESSED HAND ACTIVATE SEALER/DIVIDER | Ascent Healthcare Solutions | 2011-11-15 | 160 | 0 |
| K110189 | REPROCESSED ELECTROSURGICAL INSTRUMENT | Ascent Healthcare Solutions | 2011-07-18 | 175 | 0 |
| K090661 | NES REPROCESSED VARICOSE VEIN RF CATHETER | Northeast Scientific, Inc. | 2010-07-21 | 496 | 0 |
| K073613 | REPROCESSED SCISSOR TIPS | Sterilmed, Inc. | 2008-02-12 | 53 | 2 |
| K052690 | SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS | Suretek Medical | 2006-05-12 | 226 | 0 |
| K052692 | SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES | Suretek Medical | 2006-05-10 | 224 | 0 |
| K052695 | SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS | Suretek Medical | 2006-05-10 | 224 | 0 |
| K043198 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS | Vanguard Medical Concepts, Inc. | 2005-05-27 | 190 | 1 |
| K012598 | REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS | Sterilmed, Inc. | 2001-11-07 | 89 | 1 |
| K012603 | REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INST | Alliance Medical Corp. | 2001-11-07 | 86 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda