# K042160: Sonosurg Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Aomori Olympus Co., Ltd.
- Decided: Jan 25, 2005 after 168 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 K801623 (1980). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000095: Olympus Sonosurg Trocar XT3900 System, The Olympus Optical Co. (2000) Summary page 2.
- K021962: Olympus Ultrasonic Surgical System, The Olympus Optical Co. (2003) Summary page 2.
- K031305: Olympus Ultrasonic Surgical System, Olympus Optical Co., Ltd. (2003) Summary page 2.
- K031523: Olympus Ultrasonic Surgical System, Aomori Olympus Co., Ltd. (2003) Summary page 2.
- K031710: Olympus Ultrasonic Surgical System, Aomori Olympus Co., Ltd. (2003) Summary page 2.

## Indications for use
This instrument has been designed to be used with the SonoSurg generator (SonoSurg-G2) and is inserted into the body cavity wall by means of ultrasonic waves under endoscopic surgery in order to coagulate and cut soft tissue as well as to place a trocar tube within the body cavity wall. This instrument has been designed to be used with the SonoSurg transducers and the SonoSurg ultrasonic surgical instruments for soft tissue cutting and coagulation for laparoscopic and general (open) surgery in intraabdominal and obstetric/gynecologic procedures, and endoscopic and general surgery in ENT (Ears, Nose, Throat), thoracic, and urologic procedures. This instrument may also be combined with the SonoSurg Inigation Unit (SonoSurg-IU). Please refer to the SonoSurg-IU instruction manual to review the intended use of this combined system. This instrument may also be combined with the SonoSurg Trocar. Please refer to the SonoSurg Trocar instruction manual to review the intended use of this combined system.

Source page: https://510kreport.com/device/K042160
Methodology: https://510kreport.com/methodology