# K991218: Oratec Bipolar Ablation Probes

- Pathway: 510(k) (Traditional)
- Applicant: Oratec Interventions, Inc.
- Decided: Sep 13, 1999 after 154 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.
24 later devices descend from it; 3 cite it directly.
0 of 25 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) ArthroCare Ablation Probes: named in the summary without a submission number

## Most influential descendants
- K031371: Saphyre Bipolar Ablation Probes (2003), 19 descendants of its own
- K043442: Stryker RF Coaxial Bipolar Electrodes & Cannulae (2005), 17 descendants of its own
- K153272: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (2016), 7 descendants of its own
- K061660: Stryker RF Parallel Bipolar Adaptor Cable (2006), 5 descendants of its own
- K180369: Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (2018), 4 descendants of its own

## Indications for use
The Bipolar Ablation Probes are disposable, bipolar electrosurgical devices intended to be used for ablation and hemostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.

Source page: https://510kreport.com/device/K991218
Methodology: https://510kreport.com/methodology