# K123640: TX1 Tissue Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Tenex Health
- Decided: Mar 20, 2013 after 114 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K884413 (1988). 9 ancestors in all.
2 later devices descend 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)
- K101561: TX1 Tissue Removal System, American Optisurgical, Inc. (2010) Summary page 1.

## Most influential descendants
- K153299: Tenex Health TX System (2016), 1 descendant of its own
- K212049: Oclet TDS 1000 (2022), 0 descendants of its own

## Recalls of this device
- Apr 14, 2014 · Class II · Z-1552-2014: The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mech

## Indications for use
The TX1 Tissue Removal 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/K123640
Methodology: https://510kreport.com/methodology