# K153299: Tenex Health TX System

- Pathway: 510(k) (Traditional)
- Applicant: Tenex Health, Inc.
- Decided: Mar 3, 2016 after 111 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K884413 (1988). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123640: TX1 Tissue Removal System, Tenex Health (2013) Summary page 4.

## Most influential descendants
- K212049: Oclet TDS 1000 (2022), 0 descendants of its own

## Indications for use
The Tenex Health TX System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

Source page: https://510kreport.com/device/K153299
Methodology: https://510kreport.com/methodology