510(k) · Cleared
Recalled · 2011Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Celon AG Medical Instruments · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 8, 2008 as substantially equivalent to K023886 (Erbe USA, Inc., 2002) and 2 other predicates after a 177-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it. It has been recalled once.
- Decided
- May 8, 2008
- Review
- 177 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K933002 (1994). 4 ancestors in all, the oldest K933157 (1994). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 1 generation backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- This deviceK073207 Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments · 2008
- Descendant · cites it directly · 2 of its ownK113119 Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK113265 Genii GI 4000 Electrosugical GeneratorGenii, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK100899 Olympus Endoscopic Flushing Pump, Model Opf-2Keymed (Medical & Industrial Equipment), Ltd. · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK250657 gi2000 Electrosurgical GeneratorCintron Medical Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK241704 Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K113119Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012 · cites it directly2descendants
- K113265Genii GI 4000 Electrosugical GeneratorGenii, Inc. · 2012 · cites it directly1descendant
- K100899Olympus Endoscopic Flushing Pump, Model Opf-2Keymed (Medical & Industrial Equipment), Ltd. · 2010 · cites it directly1descendant
- K250657gi2000 Electrosurgical GeneratorCintron Medical Corporation · 2025 · 2 generations on0descendants
- K241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −1 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| 0 (this device) | K073207 | Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167 | Celon AG Medical Instruments | 2008 | — |
| +1 | K113119 | Endogator Advantage Irrigation Pump | Byrne Medical, Inc. | 2012 | — |
| +1 | K113265 | Genii GI 4000 Electrosugical Generator | Genii, Inc. | 2012 | — |
| +1 | K100899 | Olympus Endoscopic Flushing Pump, Model Opf-2 | Keymed (Medical & Industrial Equipment), Ltd. | 2010 | 3 |
| +2 | K250657 | gi2000 Electrosurgical Generator | Cintron Medical Corporation | 2025 | — |
| +2 | K241704 | Endoscopic Water Pump | Hangzhou AGS MedTech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 DSummary page 1…e Class: II Legally Marketed Trade Name 51 0(k) Applicant Predicate Devices: Erbe VIO ESU (Model K023886 Erbe USA, Inc. VIO 300 D) with Ac- cessories… | 2002 |
| * | K933157 | Erbotom Icc 200Summary page 2…II Legally Marketed Trade Name 510(k) Applicant Predicate Devices: ERBOTOM ICC 200 K933157 Erbe USA, Inc. Erbe VIO ESU (Model VIO K023886 Erbe USA, Inc.… | 1994 |
| * | K000948 | Olympus Endoscopic Flushing Pump Model Ofp-1Summary page 2…II Legally Marketed Trade Name 510(k) Applicant Predicate Devices: OLYMPUS ENDOSCOPIC K000948 KeyMed (Medical & FLUSHING PUMP MODEL Industrial Equip-… | 2000 |
| * | — | Erbe Eip 2 Named without a submission number |
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2011 | Not classified | Z-0747-2012 | Nonconforming Material/Component | Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K113119 (Byrne Medical, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K023886.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Olympus Electrosurgical System is an electrosurgical system consisting of the Olympus ESG-100 electrosurgical generator, in conjunction with the footswitch and the peristaltic flushing pump Olympus AFU-100. The Olympus ESG-100 is designed to perform monopolar and bipolar functions in the operating arena. The AFU-100 flushing pump is intended for irrigation of instruments or irrigation/flushing/cleansing of tissue surfaces and wounds supporting endoscopic diagnosis or therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073207: Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073207
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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