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 15, 2016 as substantially equivalent to K133338 (Covidien, Formerly Valleylab, A Division of Tyco H, 2013) after a 168-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jan 15, 2016
- Review
- 168 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K932293 (1994). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 5 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 4 generations backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- 3 generations backK102470 Lugasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, · 2011
- 2 generations backK113572 Ligasure Curved, Small Jaw, Open Sealer/DividerCovidien, Formerly Valleylab, A Division of Tyco H · 2012
- 1 generation backK133338 Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Covidien, Formerly Valleylab, A Division of Tyco H · 2013
- This deviceK152134 Reprocessed Vessel SealerSterilmed, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −5 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −4 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| −3 | K102470 | Lugasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, | 2011 | — |
| −2 | K113572 | Ligasure Curved, Small Jaw, Open Sealer/Divider | Covidien, Formerly Valleylab, A Division of Tyco H | 2012 | — |
| −1 | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX) | Covidien, Formerly Valleylab, A Division of Tyco H | 2013 | — |
| 0 (this device) | K152134 | Reprocessed Vessel Sealer | Sterilmed, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K133338 | Ligasure 5 MM Maryland Jaw Sealer/Divider One-Step Sealing (LF 17XX)Summary page 6…Device Regulation: 878.4400 Product Code: NUJ Predicate Device: Covidien LigaSureTM 5 mm, Maryland Jaw Sealer/Dividers (K133338). Device The reprocessed vessel sealer is a sterile, hand-held bipolar RF Description: electrosurgical instru… | 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 22 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 14 ancestors have a recall of any class.
- 5 other devices also cite its predicate K133338.
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 vessel sealer/dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the jaws of the instrument. A blade within the instrument…
Read the full statement (156 words)
The reprocessed vessel sealer/dividers are bipolar electrosurgical instruments intended for use with the ForceTriad™ Energy Platform in general, minimally invasive and open surgical procedures where ligation and division of vessels and lymphatics is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymphatics) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
Indications for use include general open and minimally invasive 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 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/K152134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152134: Reprocessed Vessel Sealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152134
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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