510(k) · Cleared
ClearedReprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Cleared on Feb 23, 2015 as substantially equivalent to K130744 (Covidien, 2013) and 1 other predicate after a 102-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Feb 23, 2015
- Review
- 102 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K932293 (1994). 12 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 backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 2 generations backK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · Recalled
- 1 generation backK123096 Reprocessed Vessel SealerSterilmed, Inc. · 2013
- This deviceK143260 Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic…Sterilmed, Inc. · 2015
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 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −2 | K092879 | Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider | Valleylab | 2009 | 1 |
| −1 | K123096 | Reprocessed Vessel Sealer | Sterilmed, Inc. | 2013 | — |
| 0 (this device) | K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider | Sterilmed, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K130744 | Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerSummary page 5…ssification: Class II Product Code: NUJ Predicate Devices: Covidien LigaSureTM 5 mm, Blunt Tip Laparoscopic Sealer/Divider (K130744). Sterilmed Reprocessed Vessel Sealer (K123096) Device Description: The reprocessed vessel sealer is… | 2013 |
| * | K123096 | Reprocessed Vessel SealerSummary page 5…NUJ Predicate Devices: Covidien LigaSureTM 5 mm, Blunt Tip Laparoscopic Sealer/Divider (K130744). Sterilmed Reprocessed Vessel Sealer (K123096) Device Description: The reprocessed vessel sealer is a sterile, hand-held bipolar RF electrosurgical… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 12 ancestors have a recall of any class.
- 3 other devices also cite its predicate K130744.
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. 2015, 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 vessel sealer/dividers are intended for use in general and gynecological laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include laparoscopically assisted vaginal hysterectomy…
Read the full statement (110 words)
The reprocessed vessel sealer/dividers are intended for use in general and gynecological laparoscopic surgical procedures where ligation and division of vessels and lymph is desired.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of the vessels is performed. These procedures include laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The reprocessed vessel sealer/dividers can be used to on vessels and lymphatics up to and including 7 mm, and tissue bundles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143260: Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic 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/K143260
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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