# K181367: Tenex Health TX System with the TXP MicroTip

- Pathway: 510(k) (Traditional)
- Applicant: Tenex Health, Inc.
- Decided: Aug 28, 2018 after 97 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: 4 generations back to K884413 (1988). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062471: Ultrasonic Surgical Aspirator System, Model FS 1000 RF, Misonix, Inc. (2006) Summary page 4.
- K050776: Auss-6 Ultrasonic Surgical Aspirator System, Misonix, Inc. (2005) Summary page 4.

## Most influential descendants
- K241700: Tenex 2nd Generation System (2024), 0 descendants of its own

## Indications for use
The Tenex Health TX System with the TXP MicroTip is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of both soft and hard (e.g.: bone) tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery. The Tenex Health TX System with the TXP MicroTip is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in which, in the physician’s judgement would require the use of an ultrasonic aspirator with sharp debridement.

Source page: https://510kreport.com/device/K181367
Methodology: https://510kreport.com/methodology