510(k) · Cleared
ClearedMini-Lap Bipolar Electrocautery Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minilap Technologies · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 3, 2012 as substantially equivalent to K023813 (Richard Wolf Medical Instruments Corp., 2003) and 1 other predicate after a 181-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Jun 3, 2012
- Review
- 181 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945975 (1994). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 3 generations backK971565 Bicoag Coagulating ForcepsEverest Medical Corp. · 1998
- 2 generations backK012279 Patton TripolPatton Medical Corp. · 2002
- 1 generation backK023813 Bipolar ForcepsRichard Wolf Medical Instruments Corp. · 2003
- This deviceK113597 Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012
- Descendant · cites it directly · 0 of its ownK172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip…Teleflexmedical, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −4 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −3 | K971565 | Bicoag Coagulating Forceps | Everest Medical Corp. | 1998 | — |
| −2 | K012279 | Patton Tripol | Patton Medical Corp. | 2002 | — |
| −1 | K023813 | Bipolar Forceps | Richard Wolf Medical Instruments Corp. | 2003 | — |
| 0 (this device) | K113597 | Mini-Lap Bipolar Electrocautery Devices | Minilap Technologies | 2012 | — |
| +1 | K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K023813 | Bipolar ForcepsSummary page 2…PAG~OFr Predicate Device [21 CFR 807.92(a)(3)] The following devices have been identified as predicate devices: * Wolf Medical Instruments Bipolar Forceps - K0238 13 " MINI LAP Instruments - K070686 Description of the Device [21 CFR 807.92(a)(4)] The MiniLap Bipolar Electrocautery devi… | 2003 |
| * | K070686 | Mini Lap InstrumentsSummary page 2…2(a)(3)] The following devices have been identified as predicate devices: * Wolf Medical Instruments Bipolar Forceps - K0238 13 " MINI LAP Instruments - K070686 Description of the Device [21 CFR 807.92(a)(4)] The MiniLap Bipolar Electrocautery devices are a family of disposable bipolar el… | 2007 |
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 |
|---|---|---|---|
| K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | 2018 | 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 18 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K172775 (Teleflexmedical, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023813.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 MiniLap Technologies family of Bipolar instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic and endoscopic procedures for manipulation and coagulation of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113597 · printed Nov 4, 2026
Cite this page
510(k) Report. “K113597: Mini-Lap Bipolar Electrocautery Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K113597
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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