# K100641: Intracept Flexible BI-Polar RF Probe and Easy Access Instrument Set, Model FG0018 (Probe), FG0036 (Instrument Set)

- Pathway: 510(k) (Special)
- Applicant: Relievant Medsystems
- Decided: Mar 30, 2010 after 25 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 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) Relievant MedSystems INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set: named in the summary without a submission number

## Most influential descendants
- K153272: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (2016), 7 descendants of its own
- K180369: Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (2018), 4 descendants of its own
- K170827: INTRACEPT Intraosseous Nerve Ablation System (2017), 4 descendants of its own
- K190504: Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator (2019), 3 descendants of its own
- K213836: Intracept Intraosseous Nerve Ablation System (2022), 1 descendant of its own

## Indications for use
The INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set is intended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues.

Source page: https://510kreport.com/device/K100641
Methodology: https://510kreport.com/methodology