510(k) · Cleared
Recalled · Class II · 2025Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instrument Service and Savings Inc.(Dba Medline Ren · NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Cleared on May 2, 2016 as substantially equivalent to K123444 (Covidien, Formerly Valleylab, A Division of Tyco H, 2013) after a 125-day review. Its family tree reaches back 5 generations to 1994. It has been recalled 4 times.
- Decided
- May 2, 2016
- Review
- 125 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 5 generations to K932293 (1994). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 4 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 3 generations backK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
- 2 generations backK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
- 1 generation backK123444 Ligasure Impact Curved, Large Jaw, Open Sealer / DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2013
- This deviceK153745 Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −4 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −3 | K051644 | Valleylab Forcetriad Electrosurgical Generator | Valleylab | 2005 | — |
| −2 | K070162 | Forcetriad Electrosurgical Generator; Ligasure Instruments | Valleylab,A Division of Tyco Healthcare Group LP | 2007 | — |
| −1 | K123444 | Ligasure Impact Curved, Large Jaw, Open Sealer / Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| 0 (this device) | K153745 | Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NUJ device
- #1 K220411 Reprocessed LigaSure Curved, Small Jaw, Open…score 8.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123444 | Ligasure Impact Curved, Large Jaw, Open Sealer / DividerSummary page 5…Product code: NUJ Classification Class: Class II, non-exempt Classification Number: 21 CFR § 878.4400 Predicate K123444 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider LF4318 Device The reprocessed Medline ReNewal LigaSure Im… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2025 | Class II | Z-0468-2026 | Under Investigation by firm | Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. |
| Oct 1, 2025 | Class II | Z-0469-2026 | Under Investigation by firm | Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged. |
| May 7, 2024 | Class II | Z-3094-2024 | Under Investigation by firm | Potential for an incomplete seal on the packaging tray. |
| Aug 3, 2023 | Class II | Z-0119-2024 | Packaging | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 14 ancestors have a recall of any class.
- 6 other devices also cite its predicate K123444.
How does its category compare?
All NUJ devicesNUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NUJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NUJ
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUJ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUJ
38in 2025
MAUDE reports naming product code NUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 2 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 39 |
| 2013 | 2 | — | 0 | 161 |
| 2014 | 1 | — | 0 | 74 |
| 2015 | 2 | — | 0 | 25 |
| 2016 | 5 | 155 | 0 | 52 |
| 2017 | 3 | 49 | 0 | 51 |
| 2018 | 7 | 88 | 0 | 14 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 59 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 2 | — | 0 | 31 |
| 2023 | 1 | — | 3 | 27 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 0 | — | 11 | 38 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LF4318 is intended to be used with the ForceTriad energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. The indications for use include open procedures (general, urologic…
Read the full statement (143 words)
The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LF4318 is intended to be used with the ForceTriad energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Impact 4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.
The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153745: Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153745
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026