510(k) · Cleared
Recalled · Class II · 2025Medline ReNewal Reprocessed LigaSure Blunt Tip 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. · NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Cleared on Jul 20, 2016 as substantially equivalent to K142929 (Covidien, 2015) after a 163-day review. Its family tree reaches back 8 generations to 1994. It has been recalled 6 times.
- Decided
- Jul 20, 2016
- Review
- 163 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 8 generations to K932293 (1994). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 7 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 6 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 5 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 4 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 3 generations backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- 2 generations backK141153 Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip…Covidien · 2014
- 1 generation backK142929 Ligasure Blunt Tip Sealer/DividerCovidien · 2015
- This deviceK160333 Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/DividerSurgical Instrument Service and Savings, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −7 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −6 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −5 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −4 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −3 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| −2 | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider… | Covidien | 2014 | — |
| −1 | K142929 | Ligasure Blunt Tip Sealer/Divider | Covidien | 2015 | — |
| 0 (this device) | K160333 | Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider | Surgical Instrument Service and Savings, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 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 |
|---|---|---|---|
| * | K142929 | Ligasure Blunt Tip Sealer/DividerSummary page 6…Electrosurgical cutting and coagulation device and accessories Classification Product code: NUJ Class: Class II, non-exempt Predicate K142929 LigaSure Blunt Tip Sealer/Divider Device Reference K141153 LigaSure; Curved Small Jaw Sealer/Divider, 5mm Blunt Tip Devic… | 2015 |
| † | K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw… | 2014 |
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-0471-2026 | 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-0472-2026 | 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-0473-2026 | 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-0474-2026 | 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-3092-2024 | Under Investigation by firm | Potential for an incomplete seal on the packaging tray. |
| Aug 3, 2023 | Class II | Z-0117-2024 | Packaging | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. |
The 5 latest of 6 recalls; the web page lists all.
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 1.6 years on median.
- 6 of the 23 ancestors have a recall of any class.
- 1 other device also cites its predicate K142929.
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 Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialities as urologic, vascular, thoracic and…
Read the full statement (112 words)
The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialities as urologic, vascular, thoracic and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
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/K160333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160333: Medline ReNewal Reprocessed LigaSure Blunt Tip 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/K160333
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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