# K071759: LTC Vad System, Models #Vad.400 (Electrosurgical Generator); PCS-900 and PCC-900 (Hand Piece Instruments)

- Pathway: 510(k) (Traditional)
- Applicant: Live Tissue Connect, Inc.
- Decided: Jul 30, 2008 after 398 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K936109 (1994). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981916: Ligasure Vessel Sealing System, Valleylab, Inc. (1998) Summary page 1.
- K063195: Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044, Valleylab (2006) Summary page 1.
- K050550: Gyrus General Purpose Electrosurgical Generator, Gyrus Medical, Inc. (2005) Summary page 1.
- K024286: Gyrus Open Forceps, Gyrus Medical, Inc. (2003) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K071759
Methodology: https://510kreport.com/methodology
