510(k) · Cleared
ClearedElectrosurgical Generator ESG-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 4, 2016 as substantially equivalent to K141225 (Olympus Winter & Ibe GmbH, 2014) and 2 other predicates after a 58-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- May 4, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K943450 (1995). 48 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations between
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK030557 Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
- 1 generation backK040638 Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004
- This deviceK160639 Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH · 2016
Show all 9 generations
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK030557 Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
- 1 generation backK040638 Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004
- This deviceK160639 Electrosurgical Generator ESG-200Olympus Winter & Ibe GmbH · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −8 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −3 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −2 | K030557 | Modification to Vnus Closure System | Vnus Medical Technologies, Inc. | 2003 | — |
| −1 | K040638 | Vnus Radiofrequency Generator, Model RFG2 | Vnus Medical Technologies, Inc. | 2004 | — |
| 0 (this device) | K160639 | Electrosurgical Generator ESG-200 | Olympus Winter & Ibe GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 10 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K141225 | Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordSummary page 4…CISION / CELON ELITE) of the proposed ESG-200 are considered substantially equivalent to the following legally marketed device: • Olympus ESG-400 (Primary Predicate, K141225) Both ESG-200 variants also have two secondary predicates for specific features as identified below: Subject device variant… | 2014 |
| * | K040638 | Vnus Radiofrequency Generator, Model RFG2Summary page 4…pecific features as identified below: Subject device variant Secondary predicate 510(k) No CELON PRECISION VNUS Radiofrequency K040638 ESG-200 Generator, Model RFG2 CELON ELITE ESG-200 Celon Lab ENT K032838 Table 2.1… | 2004 |
| * | K032838 | Celon Ent SystemSummary page 4…SION VNUS Radiofrequency K040638 ESG-200 Generator, Model RFG2 CELON ELITE ESG-200 Celon Lab ENT K032838 Table 2.1: secondary predicate devices for a few specific features… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 48 ancestors have a recall of any class.
- 5 other devices also cite its predicate K141225.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Electrosurgical generator intended for tissue cutting and coagulation in conjunction with electrosurgical accessories and ancillary equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160639 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160639: Electrosurgical Generator ESG-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160639
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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