510(k) · Cleared
ClearedLigasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 29, 2006 as substantially equivalent to K031011 (Valleylab, Inc., 2003) and 3 other predicates after a 40-day review. Its family tree reaches back 3 generations to 1994. 31 later devices descend from it.
- Decided
- Nov 29, 2006
- Review
- 40 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K932293 (1994). 12 ancestors in all, the oldest K904560 (1990). 31 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 2 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 1 generation backK031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 2003 · Recalled
- This deviceK063195 Ligasure Advance Laparoscopic Sealer/Divider with Dissecting…Valleylab · 2006
- Descendant · cites it directly · 24 of its ownK081129 Enseal…Surgrx, Inc. · 2008
- Descendant · 2 generations on · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
- Descendant · 2 generations on · 11 of its ownK101990 Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011
- Descendant · 3 generations on · 9 of its ownK141122 Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014
- Descendant · 3 generations on · 9 of its ownK132703 ThunderbeatOlympus Medical Systems Corp. · 2014
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K081129Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD…Surgrx, Inc. · 2008 · cites it directly24descendants
- K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · 2 generations on11descendants
- K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC · 2011 · 2 generations on11descendants
- K141122Harmonic Scallop Blade, Generator G11Ethicon Endo-Surgery, LLC · 2014 · 3 generations on9descendants
- K132703ThunderbeatOlympus Medical Systems Corp. · 2014 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −2 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −1 | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 | Valleylab, Inc. | 2003 | 2 |
| 0 (this device) | K063195 | Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models… | Valleylab | 2006 | — |
| +1 | K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | Surgrx, Inc. | 2008 | — |
| +2 | K111202 | Surgical Tissue Management System | Olympus Medical Systems Corp. | 2012 | 10 |
| +2 | K101990 | Ethicon Endo-Surgery Generator G11, Model GEN11 | Ethicon Endo-Sugery, LLC | 2011 | — |
| +3 | K141122 | Harmonic Scallop Blade, Generator G11 | Ethicon Endo-Surgery, LLC | 2014 | — |
| +3 | K132703 | Thunderbeat | Olympus Medical Systems Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K031011 | Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Summary page 1…ologic Electrocautery and Accessories 3. Predicate Devices The Valleylab LigaSure AdvanceTM is substantially equivalent to the Valleylab LigaSure TMLS1500 (K0310111 and K043273) and the Valleylab Laparoscopic Electrode E2774-28 (K904560 and K964175). The LigaSure Advance TM and the… | 2003 |
| * | K043273 | Ligasure Vessel Sealing System. Ligasure InstrumentsSummary page 1…ocautery and Accessories 3. Predicate Devices The Valleylab LigaSure AdvanceTM is substantially equivalent to the Valleylab LigaSure TMLS1500 (K0310111 and K043273) and the Valleylab Laparoscopic Electrode E2774-28 (K904560 and K964175). The LigaSure Advance TM and the LigaSure TM… | 2005 |
| * | K904560 | Valleylab Laparoscopic Handswitch/ElectrodesSummary page 1…lab LigaSure AdvanceTM is substantially equivalent to the Valleylab LigaSure TMLS1500 (K0310111 and K043273) and the Valleylab Laparoscopic Electrode E2774-28 (K904560 and K964175). The LigaSure Advance TM and the LigaSure TM LS1SOO are used in laparoscopic surgery to seal vessels by t… | 1990 |
| * | K964175 | Valleylab E2750 Laparoscopic Handset, Valleylab E2770 Series ElectrodesSummary page 1…AdvanceTM is substantially equivalent to the Valleylab LigaSure TMLS1500 (K0310111 and K043273) and the Valleylab Laparoscopic Electrode E2774-28 (K904560 and K964175). The LigaSure Advance TM and the LigaSure TM LS1SOO are used in laparoscopic surgery to seal vessels by the applicati… | 1996 |
| † | K051644 | Valleylab Forcetriad Electrosurgical Generator | 2005 |
What descends from it? (31)
See all 315 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081129 | Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD… | 2008 | 24 |
| K152219 | PK AIM | 2015 | 3 |
| K150835 | LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip | 2015 | 1 |
| K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/Divider | 2016 | 0 |
| K071759 | LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand… | 2008 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K081129 (Surgrx, Inc., 2008) has gone furthest, with 24 descendants of its own.
- 8 other devices also cite its predicate K031011.
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?
The Valleylab LigaSure AdvanceTM is a 5mm laparoscopic, electrosurgical instrument that incorporates both monopolar and LigaSureTM tissue fusion (bipolar) functionality. It is intended for use with the Valleylab ForceTriadEM energy platform (electrosurgical generator) in general and gynecological, laparoscopic, surgical procedures where ligation and division of vessels, including lymph vessels, is desired. The monopolar feature of the instrument will be…
Read the full statement (176 words)
The Valleylab LigaSure AdvanceTM is a 5mm laparoscopic, electrosurgical instrument that incorporates both monopolar and LigaSureTM tissue fusion (bipolar) functionality. It is intended for use with the Valleylab ForceTriadEM energy platform (electrosurgical generator) in general and gynecological, laparoscopic, surgical procedures where ligation and division of vessels, including lymph vessels, is desired. The monopolar feature of the instrument will be used where electrical dissection through tissue planes and creation of cnterotomies or gastrotomies is desired.
Indications for use include general and gynecological, laparoscopic surgical procedures (including urologic, vascular, thoracic and thoracoscopic) where electrosurgical ligation and division of vessels, including lymph vessels, is performed. These procedures include: laparoscopic gastric bypass, laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, laparoscopic colectomy, adhesiolysis, oophorectomy, etc.
The Valleylab LigaSure AdvanceTM can be used on vessels up to and including 7mm diameter and tissue bundles as large as will fit in the jaws of the instrument.
The Valleylab LigaSure AdvanceTM has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063195: Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063195
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