# K003126: Bipolar Trigger-Flex Probe

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Intl., Inc.
- Decided: Apr 11, 2001 after 188 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.
10 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K130110: Meddusa Bipolar System (2013), 4 descendants of its own
- K190336: Soniquence Bipolar Electrodes (2019), 3 descendants of its own
- K202558: Ellusa Bipolar Wands (2020), 1 descendant of its own
- K170377: TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM (2017), 1 descendant of its own
- K161378: joimax Electrosurgical Instruments (2016), 1 descendant of its own

Source page: https://510kreport.com/device/K003126
Methodology: https://510kreport.com/methodology