# K083856: Intracept Flexible BI-Polar RF Probe and Curved Instrument Set, Models: FG0018, FG0026

- Pathway: 510(k) (Special)
- Applicant: Relievant Medsystems, Inc.
- Decided: Jan 22, 2009 after 29 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: 4 generations back to K991218 (1999). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070443: Intracept BI-Polar RF Probe, Model 04814, Relievant Medsystems, Inc. (2007) Summary page 2.

## Indications for use
The INTRACEPT Flexible Bi-Polar RF Probe and Curved 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/K083856
Methodology: https://510kreport.com/methodology