510(k) · Cleared
ClearedENDOPLUS hand-held laparoscopic instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endoplus · HFI Coagulator, Culdoscopic (And Accessories)
Cleared on Dec 23, 2015 as substantially equivalent to K062072 (PAJUNK GmbH Medizintechnologie, 2006) after a 196-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Dec 23, 2015
- Review
- 196 days
- Class
- Class II
- Product code
- HFI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935270 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK935270 Modular Forcep and Scissor SystemRichard Wolf Medical Instruments Corp. · 1994
- 2 generations backK033249 Pajunk Modular Handle InstrumentsPajunk GmbH · 2004
- 1 generation backK062072 Pajunks Disposable Inserts for Handle Instruments and HF ElectrodesPAJUNK GmbH Medizintechnologie · 2006
- This deviceK151567 ENDOPLUS hand-held laparoscopic instrumentsEndoplus · 2015
- Descendant · cites it directly · 0 of its ownK193018 Surgical Direct Hand-held Laparoscopic InstrumentsSurgical Direct, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K193018Surgical Direct Hand-held Laparoscopic InstrumentsSurgical Direct, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935270 | Modular Forcep and Scissor System | Richard Wolf Medical Instruments Corp. | 1994 | — |
| −2 | K033249 | Pajunk Modular Handle Instruments | Pajunk GmbH | 2004 | — |
| −1 | K062072 | Pajunks Disposable Inserts for Handle Instruments and HF Electrodes | PAJUNK GmbH Medizintechnologie | 2006 | — |
| 0 (this device) | K151567 | ENDOPLUS hand-held laparoscopic instruments | Endoplus | 2015 | — |
| +1 | K193018 | Surgical Direct Hand-held Laparoscopic Instruments | Surgical Direct, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 HFI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K062072 | Pajunks Disposable Inserts for Handle Instruments and HF ElectrodesSummary page 4…Manufacturer Brand Name 510(k) Number Pajunk GmbH Medizintechnologie Pajunks disposable inserts for K062072 handled instrument and HF Electrodes DE… | 2006 |
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 |
|---|---|---|---|
| K193018 | Surgical Direct Hand-held Laparoscopic Instruments | 2019 | 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 21 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K193018 (Surgical Direct, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HFI devicesHFI Coagulator, Culdoscopic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HFI
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HFI
Too few HFI 510(k)s in any year since 2007 to give a median.
Recalls per year · HFI
No recall names HFI since 2007.
Adverse event reports per year · HFI
1in 2025
MAUDE reports naming product code HFI, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Endoplus Hand held Laparoscopic instruments are intended for grasping, cutting, dissecting, retracting, clamping, biopsy, and/or cauterization of tissue. The devices are used in conjunction with a laparoscope during laparoscopic procedures. Instruments should be used only by personnel completely familiar with their operation. Using an instrument improperly for a task which it was not intended may result in a damaged or broken instrument.
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/K151567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151567: ENDOPLUS hand-held laparoscopic instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151567
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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