510(k) · Cleared
ClearedLaparoscopic FMsealer
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 Jan 2, 2015 as substantially equivalent to K043273 (Valleylab, 2005) and 1 other predicate after a 142-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jan 2, 2015
- Review
- 142 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K933157 (1994). 34 ancestors in all, the oldest K780977 (1978). No later device cites it as a predicate yet.
- Root · 7 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 6 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 5 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- 4 generations backK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- 3 generations backK121881 Domain Surgical SystemDomain Surgical, Inc. · 2012
- 2 generations backK130606 Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014
- 1 generation backK141484 Open FmsealerDomain Surgical, Inc. · 2014 · Recalled
- This deviceK142229 Laparoscopic FMsealerDomain Surgical, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −6 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −5 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| −4 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| −3 | K121881 | Domain Surgical System | Domain Surgical, Inc. | 2012 | — |
| −2 | K130606 | Fmwand Ferromagnetic Surgical System | Domain Surgical, Inc. | 2014 | — |
| −1 | K141484 | Open Fmsealer | Domain Surgical, Inc. | 2014 | 1 |
| 0 (this device) | K142229 | Laparoscopic FMsealer | Domain Surgical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1985 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K043273 | Ligasure Vessel Sealing System. Ligasure InstrumentsSummary page 4…agulation device and accessories (21 CFR §878.4400) Regulatory Class: Il Product Code: GEI PREDICATE DEVICES LigaSure Vessel Sealing System (Product Code GEIl) 510(k) #K043273 Open FMsealer (Product Code GEIl) 510(k) #K141484 No reference devices were used in this submission. DEVICE DESCRIPTION Electr… | 2005 |
| * | K141484 | Open FmsealerSummary page 4…) Regulatory Class: Il Product Code: GEI PREDICATE DEVICES LigaSure Vessel Sealing System (Product Code GEIl) 510(k) #K043273 Open FMsealer (Product Code GEIl) 510(k) #K141484 No reference devices were used in this submission. DEVICE DESCRIPTION Electrosurgical cutting and coagulation devices (and acc… | 2014 |
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 5 companies; a new generation was cleared every 2.4 years on median.
- 9 of the 34 ancestors have a recall of any class.
- 4 other devices also cite its predicate K043273.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Laparoscopic FMsealer is an electrosurgical instrument intended for use in open and laparoscopic surgical procedures, including general and gynecologic procedures where ligation and division of vessels, including lymph vessels, is desired. It can be used to ligate and divide vessels up to and including 7 mm and bundles as large as will fit in the jaws of the instrument.
The Laparoscopic FMsealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these purposes.
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/K142229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142229: Laparoscopic FMsealer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142229
Report an extraction error
Are you the manufacturer?
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