# K994333: Ora-50 Electrothermal System and Accessories

- Pathway: 510(k) (Special)
- Applicant: Oratec Interventions, Inc.
- Decided: Jan 18, 2000 after 26 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: 1 generation back to K964071 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964071: Oratec Interventions Model Ora 50 Electrothermal Generator, Oratec Interventions, Inc. (1996) Summary page 1.

## Indications for use
The ORA-50 ElectroThermal System (“ORA-50”) and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues. The ORA-50 ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical generators. Contraindications for Use: The ORA-50 ElectroThermal System and Accessories are contraindicated, when in the judgement of the physician, an electrosurgical procedure would be contrary to the best interests of the patient.

Source page: https://510kreport.com/device/K994333
Methodology: https://510kreport.com/methodology