510(k) · Cleared
ClearedGenii GI 4000 Electrosugical Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genii, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 22, 2012 as substantially equivalent to K073207 (Celon AG Medical Instruments, 2008) and 3 other predicates after a 139-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Mar 22, 2012
- Review
- 139 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K894762 (1989). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 2 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
- 1 generation backK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
- This deviceK113265 Genii GI 4000 Electrosugical GeneratorGenii, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK250657 gi2000 Electrosurgical GeneratorCintron Medical Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K250657gi2000 Electrosurgical GeneratorCintron Medical Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894762 | B100 Disposable Handpiece | Beacon Laboratories, Inc. | 1989 | — |
| −2 | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator… | Erbe USA, Inc. | 1996 | — |
| −1 | K013348 | Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158… | Erbe USA, Inc. | 2001 | — |
| 0 (this device) | K113265 | Genii GI 4000 Electrosugical Generator | Genii, Inc. | 2012 | — |
| +1 | K250657 | gi2000 Electrosurgical Generator | Cintron Medical Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K073207 | Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Summary page 2…nnect"M Conducting Adapter is intended for use with the gi4000 during argon assisted coagulation. Predicate Devices: 1. Olympus AFU-100 Peristaltic Pump Unit (PPU); K073207 2. Erbe APC 300 Argon Plasma Coagulator and Accessories; K963189 3. Erbe ]CC 200 Electrosurgical Workstation for Flexible E… | 2008 |
| * | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…Summary page 2…g argon assisted coagulation. Predicate Devices: 1. Olympus AFU-100 Peristaltic Pump Unit (PPU); K073207 2. Erbe APC 300 Argon Plasma Coagulator and Accessories; K963189 3. Erbe ]CC 200 Electrosurgical Workstation for Flexible Endloscopy; K(933157 4. Erbe APC Connector Hose and Probes; K(0133… | 1996 |
| * | K933157 | Erbotom Icc 200Summary page 3…00 Erbe APC 300 Erbe ICC 200 510(k) Number NA K073207 K963189 K933157 Product Code GEl FEQ (with GEl) GEl GEl Regulatio… | 1994 |
| * | K013348 | Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158, 20132-155…Summary page 5…Genii Aj'Connect Erbe APC Connector Hose 510(k) Number NA K013348 Product Code GEl GEl Regulation Number 878.4400… | 2001 |
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 |
|---|---|---|---|
| K250657 | gi2000 Electrosurgical Generator | 2025 | 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 23 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K250657 (Cintron Medical Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K073207.
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 gi4000 Electrosurgical Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated lavage pump is intended to wash tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope waterjet channels, or endloscope working channels. The Genii ArConnect" Conducting Adapter is intended for use with the gi4000 during argon assisted coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113265 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113265: Genii GI 4000 Electrosugical Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113265
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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