510(k) · Cleared
ClearedLTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand Piece Instruments)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Live Tissue Connect, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 30, 2008 as substantially equivalent to K981916 (Valleylab, Inc., 1998) and 3 other predicates after a 398-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Jul 30, 2008
- Review
- 398 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K936109 (1994). 86 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations between
- 3 generations backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- 2 generations backK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004 · Recalled
- 1 generation backK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
- This deviceK071759 LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900…Live Tissue Connect, Inc. · 2008
Show all 10 generations
- Root · 10 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 9 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 8 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 7 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 6 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 5 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 4 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 3 generations backK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
- 2 generations backK041285 Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and…Gyrus Medical, Ltd. · 2004 · Recalled
- 1 generation backK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
- This deviceK071759 LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900…Live Tissue Connect, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −9 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −7 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −6 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −5 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −4 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −3 | K021777 | Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and… | Gyrus Ent LLC | 2002 | — |
| −2 | K041285 | Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and… | Gyrus Medical, Ltd. | 2004 | 2 |
| −1 | K050550 | Gyrus General Purpose Electrosurgical Generator | Gyrus Medical, Inc. | 2005 | — |
| 0 (this device) | K071759 | LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and… | Live Tissue Connect, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 11 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 14 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K981916 | Ligasure Vessel Sealing SystemSummary page 1…surgical Bipolar Device Classification Name Electrosurgical Cutting and Coagulation Device and Accessories Predicate Devices LigaSure Vessel Sealing System (K981916) LigaSure Advance (K063195) Gyrus General Purpose Electrosurgical System (K050550) Gyrus OPEN FORCEPS (K024286) =… | 1998 |
| * | K063195 | Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034…Summary page 1…ication Name Electrosurgical Cutting and Coagulation Device and Accessories Predicate Devices LigaSure Vessel Sealing System (K981916) LigaSure Advance (K063195) Gyrus General Purpose Electrosurgical System (K050550) Gyrus OPEN FORCEPS (K024286) Intended Use / Ind… | 2006 |
| * | K050550 | Gyrus General Purpose Electrosurgical GeneratorSummary page 1…evice and Accessories Predicate Devices LigaSure Vessel Sealing System (K981916) LigaSure Advance (K063195) Gyrus General Purpose Electrosurgical System (K050550) Gyrus OPEN FORCEPS (K024286) Intended Use / Indications for Use The LTC VAD.400 is an electrosurgical… | 2005 |
| * | K024286 | Gyrus Open ForcepsSummary page 1…evices LigaSure Vessel Sealing System (K981916) LigaSure Advance (K063195) Gyrus General Purpose Electrosurgical System (K050550) Gyrus OPEN FORCEPS (K024286) Intended Use / Indications for Use The LTC VAD.400 is an electrosurgical generator coupled with designated… | 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 14 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 86 ancestors have a recall of any class.
- 15 other devices also cite its predicate K981916.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 LTC VAD.400 is an electrosurgical generator coupled with designated LTC electrosurgical instruments for bipolar tissue fusion. The LTC VAD.400 electrosurgical generator and designated LTC electrosurgical instruments (i.e., "the VAD System") are intended for use in open general surgical procedures where ligation of vessels and ducts is desired and as an alternative to mechanical clamping (clips or staples) or suturing. The LTC VAD System can be used…
Read the full statement (146 words)
The LTC VAD.400 is an electrosurgical generator coupled with designated LTC electrosurgical instruments for bipolar tissue fusion. The LTC VAD.400 electrosurgical generator and designated LTC electrosurgical instruments (i.e., "the VAD System") are intended for use in open general surgical procedures where ligation of vessels and ducts is desired and as an alternative to mechanical clamping (clips or staples) or suturing. The LTC VAD System can be used on vessels up to 7mm in diameter, on ducts up to 2mm in diameter, and tissue bundles as large as will fit in the jaw electrodes of the instrument.
The LTC VAD system has not yet been tested for use in tubal sterilization or tubal coagulation for sterilization procedures; therefore, the company does not recommend the use of the LTC VAD system for such procedures. In addition, LTC recommends against the use of the VAD System for male circumcisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071759 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071759: LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand Piece Instruments).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071759
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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