510(k) · Cleared
ClearedNelson Electrosurgical Unit, Model GN640
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 19, 2002 as substantially equivalent to K981220 (Aspen Laboratories, Inc., 1998) and 3 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Mar 19, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K933002 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- This deviceK014172 Nelson Electrosurgical Unit, Model GN640Aesculap, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| 0 (this device) | K014172 | Nelson Electrosurgical Unit, Model GN640 | Aesculap, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K981220 | System 7500 Abc Electrosurgical UnitSummary page 1…s such as intended use, labeling, and basic operating principles to the following predicate devices: Conmed / Aspen Laboratories’ System 7500 ABC Electrosurgical Unit (#KK981220), Erbe’s Erbotom ICC 300 & 350 (#K953738 & #K933002), and ValleyLab's Force FX (#K944602). * SSRVICeg ” R “ {C… | 1998 |
| * | K953738 | Erbotom Icc 300Summary page 1…ic operating principles to the following predicate devices: Conmed / Aspen Laboratories’ System 7500 ABC Electrosurgical Unit (#KK981220), Erbe’s Erbotom ICC 300 & 350 (#K953738 & #K933002), and ValleyLab's Force FX (#K944602). * SSRVICeg ” R “ {C DEPARTMENT OF HEALTH & HUMAN SERVICES Pub… | 1995 |
| * | K933002 | Erbotom Icc 350Summary page 1…g principles to the following predicate devices: Conmed / Aspen Laboratories’ System 7500 ABC Electrosurgical Unit (#KK981220), Erbe’s Erbotom ICC 300 & 350 (#K953738 & #K933002), and ValleyLab's Force FX (#K944602). * SSRVICeg ” R “ {C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health… | 1994 |
| * | K944602 | Valleylab Force FXSummary page 1…e devices: Conmed / Aspen Laboratories’ System 7500 ABC Electrosurgical Unit (#KK981220), Erbe’s Erbotom ICC 300 & 350 (#K953738 & #K933002), and ValleyLab's Force FX (#K944602). * SSRVICeg ” R “ {C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ARALTY o ., %, b, 'y, “¥vir… | 1995 |
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?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K981220.
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?
Aesculap's Nelson Electrosurgical is intended to be used in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014172 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014172: Nelson Electrosurgical Unit, Model GN640.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014172
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026