# K974464: Oratec Spinecath Intradiscal Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Oratec Interventions, Inc.
- Decided: Mar 19, 1998 after 113 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 K896183 (1990). 5 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972358: Oratec Model Endotac Probe, Oratec Interventions, Inc. (1998). Cleared while this submission was under review Summary page 1.
- K931109: Nucleotome E Kit, Surgical Dynamics, Inc. (1994) Summary page 2.
- K942987: Nucleotome L Kit, Surgical Dynamics, Inc. (1995) Summary page 2.
- K896183: KTP/532 Surgical Laser for Percutaneous Diskectomy, Laserscope (1990) Summary page 2.
- K913758: KTP/532 and KTP/Yag, Laserscope (1991) Summary page 2.

## Most influential descendants
- 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
- K222260: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 (2023), 3 descendants of its own

## Indications for use
The Oratec SpineCATH Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

Source page: https://510kreport.com/device/K974464
Methodology: https://510kreport.com/methodology