# K014251: Ntero Hotrod System

- Pathway: 510(k) (Traditional)
- Applicant: Ntero Surgical, Inc.
- Decided: Mar 26, 2002 after 90 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: 6 generations back to K943450 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992572: Ntero RF Sleeve, Ntero Surgical, Inc. (1999) Summary page 1.
- K983743: Bisure Laparoscopic Bipolar Forceps, Valleylab, Inc. (1999) Summary page 1.
- K974521: Vnus Closure System, Vnus Medical Technologies, Inc. (1998) Summary page 1.

## Indications for use
The NTERO HOTROD System is intended to coagulate tissue during surgical procedures.

Source page: https://510kreport.com/device/K014251
Methodology: https://510kreport.com/methodology