# K032969: Helica TC Laparoscopic Cutting and Cauterising (LTC) Probe

- Pathway: 510(k) (Traditional)
- Applicant: Helica Instruments, Ltd.
- Decided: Feb 4, 2004 after 134 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: 1 generation back to K972267 (1999). 1 ancestor in all.
15 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972267: Helica TC, Tenerco, Inc. (1999) Summary page 1.

## Most influential descendants
- K050541: Omniguide Beampath CO2 Mark I Laser Beam Delivery (2005), 14 descendants of its own
- K070157: Omniguide Beam Path CO2 Mark Iii Waveguide Fiber (2007), 8 descendants of its own
- K073313: Mark Iii Waveguide Fiber with Low Profile Tip (2008), 5 descendants of its own
- K093451: Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip (2009), 4 descendants of its own
- K140378: Flexguide Ultra Beampath Robotic Fiber Conduit (2014), 2 descendants of its own

## Indications for use
The device is a helium gas electro surgical cutting and coagulator for use in all soft tissue surgery- laparoscopic, endoscopic and open.

Source page: https://510kreport.com/device/K032969
Methodology: https://510kreport.com/methodology