510(k) · Cleared
ClearedModular Laparoscopy Accessories, Handle; Sissors (Straight and Curved); Grasper (Aggressive, Allis, Ataumatic; Dissector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aaron Medical Industries · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 5, 2006 as substantially equivalent to K970541 (Aesculap, Inc., 1997) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Oct 5, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914883 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK914883 Circon Acmi Gen Surg Instru for Mini Invasive SurgCircon Video · 1993
- This deviceK062337 Modular Laparoscopy Accessories, Handle; Sissors (Straight and…Aaron Medical Industries · 2006
- Descendant · cites it directly · 0 of its ownK081431 Meg Laparoscopic ElectrodesBovie Medical · 2008
Most influential descendants
Showing 1 of 1 · See all- K081431Meg Laparoscopic ElectrodesBovie Medical · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914883 | Circon Acmi Gen Surg Instru for Mini Invasive Surg | Circon Video | 1993 | — |
| 0 (this device) | K062337 | Modular Laparoscopy Accessories, Handle; Sissors (Straight and Curved)… | Aaron Medical Industries | 2006 | — |
| +1 | K081431 | Meg Laparoscopic Electrodes | Bovie Medical | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K970541 | Aesculap Modular Monopolar ElectrodesSummary page 1…OCT -. 5 2006 DEVICE DESCRIPTION: Predicate Devices: Aesculap USA: Modular Monopolar Electrodes K970541 ACMI Circon: Surgical Instrument for Minimally Invasive Surgery K914883 INTENDED USE: Laparoscopic Electrodes and… | 1997 |
| * | K914883 | Circon Acmi Gen Surg Instru for Mini Invasive SurgSummary page 1…vices: Aesculap USA: Modular Monopolar Electrodes K970541 ACMI Circon: Surgical Instrument for Minimally Invasive Surgery K914883 INTENDED USE: Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgica… | 1993 |
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 |
|---|---|---|---|
| K081431 | Meg Laparoscopic Electrodes | 2008 | 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?
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062337: Modular Laparoscopy Accessories, Handle; Sissors (Straight and Curved); Grasper (Aggressive, Allis, Ataumatic; Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062337
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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