510(k) · Cleared
Cleared5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Purple Surgical International Limited · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 21, 2014 as substantially equivalent to K103508 (Unimax Medical Systems, Inc., 2011) after a 51-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Nov 21, 2014
- Review
- 51 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K932832 (1994). 20 ancestors in all, the oldest K913281 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK932832 Primus Insulated ForcepsMarlo Surgical Technology · 1994
- 5 generations backK021237 Coopersurgical Laparoscopic InstrumentsCooperSurgical, Inc. · 2003
- 4 generations backK043013 Miltex Laparoscopic InstrumentsMiltex, Inc. · 2005
- 3 generations backK052759 Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · Recalled
- 2 generations backK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
- 1 generation backK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
- This deviceK142868 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode…Purple Surgical International Limited · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932832 | Primus Insulated Forceps | Marlo Surgical Technology | 1994 | — |
| −5 | K021237 | Coopersurgical Laparoscopic Instruments | CooperSurgical, Inc. | 2003 | — |
| −4 | K043013 | Miltex Laparoscopic Instruments | Miltex, Inc. | 2005 | — |
| −3 | K052759 | Dan Monopolar Lap Accessories | Dannoritzer Medizintechnik GmbH & Co. KG | 2006 | 1 |
| −2 | K081503 | Aed Monopolar Lap Accessories | National Advanced Endoscopy Devices, Inc. | 2008 | — |
| −1 | K103508 | Unmiax Laparoscopic Instrument | Unimax Medical Systems, Inc. | 2011 | — |
| 0 (this device) | K142868 | 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L… | Purple Surgical International Limited | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K103508 | Unmiax Laparoscopic InstrumentSummary page 5…Page 2 of 5 Device name / 510k: Monopolar J hook probe 5mm/33cm with cable (k103508) Monopolar L hook probe 5mm/33cm with cable (k103508) Monopolar Spatula probe 5mm/33cm wi… | 2011 |
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 20 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 20 ancestors have a recall of any class.
- 4 other devices also cite its predicate K103508.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The devices are indicated for:
use in general laparoscopic surgery requiring the use of monopolar electrosurgical cutting
and/or coagulation.
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/K142868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142868: 5mm Laparoscopic Electrode with J Hook, 5mm Laparoscopic Electrode with L Hook, 5mm Laparoscopic Electrode with Spatula, Monopolar cable with 4mm pin, Monopolar cable with 8mm pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142868
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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