# K972358: Oratec Model Endotac Probe

- Pathway: 510(k) (Traditional)
- Applicant: Oratec Interventions, Inc.
- Decided: Jan 23, 1998 after 212 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.
21 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K974464: Oratec Spinecath Intradiscal Catheter (1998), 20 descendants of its own
- K993854: Ora-50 S Autotemp Electrothermal Spine System and Accessories (1999), 16 descendants of its own
- K033981: Smith & Nephew Electrothermal 20S Spine Generator, Model 7209975 (2004), 14 descendants of its own
- K130689: Symphony RF Generator (2013), 11 descendants of its own
- K171094: Thermi Reusable Non-invasive RF Electrode (2017), 6 descendants of its own

## Indications for use
Model EndoTAC™ Monopolar Cautery Probe is designed for hemostasis, and for coagulation and desiccation of disc material to treat disc annulus disruption and degenerative disc diseases of contained herniated disc.

Source page: https://510kreport.com/device/K972358
Methodology: https://510kreport.com/methodology