# K992805: Oratec Ablator-S Probes (Monopolar Ablation Suction Probes)

- Pathway: 510(k) (Traditional)
- Applicant: Oratec Interventions, Inc.
- Decided: Feb 4, 2000 after 168 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: 2 generations back to K943450 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965007: Oratec Interventiouns Electrosurgical Probes, Oratec Interventions, Inc. (1997) Summary page 1.
- K992408: Electrosurgical Probes Family: Ligament Chisels, Micro Ligament Chisels, Ablator Probes, Oratec Interventions, Inc. (1999) Summary page 1.
- K991218: Oratec Bipolar Ablation Probes, Oratec Interventions, Inc. (1999). Cleared while this submission was under review Summary page 1.
- K943450: Arthrocare Arthroscopic Electrosurgery System Model 970, Arthrocare Corp. (1995) Summary page 1.
- K961747: Arthrocare Arthroscopic Electrosurgery System (Model 970), Arthrocare Corp. (1996) Summary page 1.
- K962321: Arthocare Arthroscopic Electrosurgery System Model 970, Arthrocare Corp. (1996) Summary page 1.

## Indications for use
The ORATEC® Ablator-S Probes are disposable, monopolar 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/K992805
Methodology: https://510kreport.com/methodology