# K013622: Nucleotomy Intradiscal Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Oratec Interventions, Inc.
- Decided: Jan 31, 2002 after 87 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: 3 generations back to K896183 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993967: Oratec Spinecath Intradiscal Catheter, Model 920002, Oratec Interventions, Inc. (1999) Summary page 1.

## Most influential descendants
- K073466: Smith & Nephew Intradiscal Catheter System (2008), 0 descendants of its own

## Indications for use
The Nucleotomy Catheter is intended to be used for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.

Source page: https://510kreport.com/device/K013622
Methodology: https://510kreport.com/methodology