510(k) · Cleared
ClearedMini Lap Electrocautery Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mini Lap Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 20, 2009 after a 338-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Nov 20, 2009
- Review
- 338 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK083754 Mini Lap Electrocautery InstrumentsMini Lap Technologies, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK153063 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK181852 Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip…Teleflexmedical, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K153063Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2016 · cites it directly1descendant
- K181852Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc. · 2018 · 2 generations on0descendants
- K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083754 | Mini Lap Electrocautery Instruments | Mini Lap Technologies, Inc. | 2009 | — |
| +1 | K153063 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2016 | 9 |
| +2 | K181852 | Percuvance Percutaneous Surgical System | Teleflexmedical, Inc. | 2018 | — |
| +1 | K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K153063 (Teleflexmedical, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 used to cut and cauterize soft tissue.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K083754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083754: Mini Lap Electrocautery Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083754
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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