510(k) · Cleared
ClearedReprocessed Vessel Sealer
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 Jan 25, 2013 as substantially equivalent to K092879 (Valleylab, 2009) and 1 other predicate after a 115-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Jan 25, 2013
- Review
- 115 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K932293 (1994). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 3 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 2 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 1 generation backK092879 Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerValleylab · 2009 · Recalled
- This deviceK123096 Reprocessed Vessel SealerSterilmed, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK143260 Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic…Sterilmed, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K143260Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/DividerSterilmed, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −3 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −2 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −1 | K092879 | Ligasure 5MM Blunt Tip Laparoscopic Sealer-Divider | Valleylab | 2009 | 1 |
| 0 (this device) | K123096 | Reprocessed Vessel Sealer | Sterilmed, Inc. | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K092879 | Ligasure 5MM Blunt Tip Laparoscopic Sealer-DividerSummary page 1…Code: NUJ Predicate The reprocessed vessel sealers are substantially equivalent to the Covidien LigaSureM Laparoscopic Devices: instruments (K092879 and K03 101lI). DevceThe vessel sealers are eiectrosurgiral instruments, for use with the ForceTriad"' energy platform when… | 2009 |
| * | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143260 | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider | 2015 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K143260 (Sterilmed, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K092879.
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. 2013, 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 sealers are indicated for use in general and gynecological, laparoscopic surgical procedures where ligation of vasculature is desired. The reprocessed vessel sealers can be used to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. The reprocessed vessel sealers can also be used to seal pulmonary vasculature when used with the ForceTriad energy platform.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123096 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123096: Reprocessed Vessel Sealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123096
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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