510(k) · Cleared
ClearedReprocessed Surgical Electric Instrument
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 Oct 5, 2012 as substantially equivalent to K070162 (Valleylab,A Division of Tyco Healthcare Group LP, 2007) after a 274-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 5, 2012
- Review
- 274 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932293 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 3 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 2 generations backK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
- 1 generation backK070162 Forcetriad Electrosurgical Generator; Ligasure InstrumentsValleylab,A Division of Tyco Healthcare Group LP · 2007
- This deviceK120040 Reprocessed Surgical Electric InstrumentSterilmed, Inc. · 2012
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 | K051644 | Valleylab Forcetriad Electrosurgical Generator | Valleylab | 2005 | — |
| −1 | K070162 | Forcetriad Electrosurgical Generator; Ligasure Instruments | Valleylab,A Division of Tyco Healthcare Group LP | 2007 | — |
| 0 (this device) | K120040 | Reprocessed Surgical Electric Instrument | Sterilmed, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K070162 | Forcetriad Electrosurgical Generator; Ligasure InstrumentsSummary page 1…tended.W Conclusion: The reprocessed sealer/divider is substantially equivalent to the Covidien Ligaure Impact Hand Activated Sealer/Divider (K070162). This conclusion is based upon the devices' similarities in functional design L (principles of operation), mat… | 2007 |
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 18 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 8 other devices also cite its predicate K070162.
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. 2012, 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 Surgical Electric instrument (hereinafter sealer/divider) is indicated for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. When used with the ForceTriad T1I energy platform the sealer/divider can also be used to seal pulmonary vasculature. The sealer/divider should not be used for tubal sterilization or tubal coagulation as it has not been shown effective for sterilization procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120040: Reprocessed Surgical Electric Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120040
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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