# K972267: Helica TC

- Pathway: 510(k) (Traditional)
- Applicant: Tenerco, Inc.
- Decided: Sep 14, 1999 after 819 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
No predicates in its family tree.
31 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Valley Lab. APEC: named in the summary without a submission number
- (no number) Erbe Apc 300: named in the summary without a submission number

## Most influential descendants
- K090586: Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable Handpiece Cable (GS807-RC) (2009), 16 descendants of its own
- K032969: Helica TC Laparoscopic Cutting and Cauterising (LTC) Probe (2004), 15 descendants of its own
- K112233: Bovie J-Plasma Handpiece with Retractable Cutting Blade (2012), 14 descendants of its own
- K050541: Omniguide Beampath CO2 Mark I Laser Beam Delivery (2005), 14 descendants of its own
- K151325: Bovie J-Plasma Handpiece (2015), 13 descendants of its own

## Indications for use
The device is a helium gas electrosurgical coagulator for use in all soft tissue surgery--laparoscopic, endoscopic, and Open.

Source page: https://510kreport.com/device/K972267
Methodology: https://510kreport.com/methodology