510(k) · Cleared
Recalled · 2008Reprocessed Laparoscopic Electric Instuments
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 Nov 7, 2001 as substantially equivalent to K945975 (Everest Medical Corp., 1994) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 7, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910831 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
- 1 generation backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
- This deviceK012598 Reprocessed Laparoscopic Electric InstumentsSterilmed, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK031869 Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments…Surgical Instruments Service and Savings, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K031869Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and AccessoriesSurgical Instruments Service and Savings, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910831 | Endopath Surgical Instruments | Symbiosis Corp. | 1991 | — |
| −1 | K984240 | Endopath Endoscopic Instruments | Ethicon Endo-Surgery, Inc. | 1999 | 1 |
| 0 (this device) | K012598 | Reprocessed Laparoscopic Electric Instuments | Sterilmed, Inc. | 2001 | — |
| +1 | K031869 | Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and… | Surgical Instruments Service and Savings, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsSummary page 5…vice Description: Intended Use: Functional and Safety Testing: NuUJ The reprocessed laparoscopic electric instruments are substantially equivalent to BiCoag Forceps (K945975), manufactured by Everest; Endopath Endoscopic Instruments (K984240); manufactured by Ethicon; and counterpart devices from other… | 1994 |
| * | K984240 | Endopath Endoscopic InstrumentsSummary page 5…UJ The reprocessed laparoscopic electric instruments are substantially equivalent to BiCoag Forceps (K945975), manufactured by Everest; Endopath Endoscopic Instruments (K984240); manufactured by Ethicon; and counterpart devices from other original equipment manufacturers. Laparoscopic electric instrument… | 1999 |
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 |
|---|---|---|---|
| K031869 | Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and Accessories | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2008 | Not classified | Z-0560-2009 | Packaging process control | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K031869 (Surgical Instruments Service and Savings, Inc., 2003) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K945975.
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.
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?
Laparoscopic Electric Instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, resection, mobilization, and dissection of tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012598 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012598: Reprocessed Laparoscopic Electric Instuments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012598
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026