510(k) · Cleared
ClearedFmwand Handpiece SE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Domain Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 23, 2014 as substantially equivalent to K130606 (Domain Surgical, Inc., 2014) and 1 other predicate after a 98-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- May 23, 2014
- Review
- 98 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K933157 (1994). 35 ancestors in all, the oldest K780977 (1978). No later device cites it as a predicate yet.
- Root · 6 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 5 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 4 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- 3 generations backK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- 2 generations backK121881 Domain Surgical SystemDomain Surgical, Inc. · 2012
- 1 generation backK130606 Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014
- This deviceK140384 Fmwand Handpiece SEDomain Surgical, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −5 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −4 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| −3 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| −2 | K121881 | Domain Surgical System | Domain Surgical, Inc. | 2012 | — |
| −1 | K130606 | Fmwand Ferromagnetic Surgical System | Domain Surgical, Inc. | 2014 | — |
| 0 (this device) | K140384 | Fmwand Handpiece SE | Domain Surgical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1985 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K130606 | Fmwand Ferromagnetic Surgical SystemSummary page 1…t use, soft tissue cutting and coagulation device intended to be used with the FMwand Generator and FMwand Power Module (both previously cleared in 510(k) #K1 30606) and also with an effective user-supplied smoke evacuation system. Technological Comparison The FMwand Handpiece SE… | 2014 |
| * | K120454 | Safeair Smoke Pencil,Summary page 1…Predicate Device(s) " FMwand Ferromagnetic Surgical System, (Product Code GEl, HGI) 510(k) #1130606 * LiNA Medical SafeAir Smoke Pencil (Product Code GEl), 510(k) #K120454 Device Description The FMwand Handpiece SE is a sterile, single-patient use, soft tissue cutting and coagulation de… | 2012 |
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 20 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 9 of the 35 ancestors have a recall of any class.
- 1 other device also cites its predicate K130606.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 FMwand Handpiece SE is indicated for cutting and coagulation of soft tissue during surgical procedures, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
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/K140384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140384: Fmwand Handpiece SE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140384
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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