# K101561: TX1 Tissue Removal System

- Pathway: 510(k) (Traditional)
- Applicant: American Optisurgical, Inc.
- Decided: Aug 27, 2010 after 84 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K884413 (1988). 8 ancestors in all.
3 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)
- K021989: Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3, Integra Neurosciences (2002) Summary page 1.

## Most influential descendants
- K123640: TX1 Tissue Removal System (2013), 2 descendants of its own
- 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
- Mar 30, 2013 · Class II · Z-1516-2013: The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making 
- Feb 22, 2012 · Class II · Z-1817-2012: Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressu

## 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/K101561
Methodology: https://510kreport.com/methodology