# K041566: Sonosurg Ultrasonic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Aomori Olympus Co., Ltd.
- Decided: Sep 8, 2004 after 90 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 K801623 (1980). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032066: Sonosurg System, The Olympus Optical Co. (2003) Summary page 2.
- K000095: Olympus Sonosurg Trocar XT3900 System, The Olympus Optical Co. (2000) Summary page 2.
- K021962: Olympus Ultrasonic Surgical System, The Olympus Optical Co. (2003)
- K031710: Olympus Ultrasonic Surgical System, Aomori Olympus Co., Ltd. (2003) Summary page 2.
- K031523: Olympus Ultrasonic Surgical System, Aomori Olympus Co., Ltd. (2003) Summary page 3.
- K031305: Olympus Ultrasonic Surgical System, Olympus Optical Co., Ltd. (2003) Summary page 3.
- K981262: Cusa Excel Ultrasonic Surgical Aspirator System, Valleylab, Inc. (1998) Summary page 2.
- K010309: Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator, Mutoh America Co., Ltd. (2001) Summary page 2.
- K962952: Olympus Ultrasonic Surgical System (Usu), Olympus Optical, Co. (1996) Summary page 2.

## Indications for use
The SonoSurg Olympus Ultrasonic Surgical System is indicated for use in surgical procedure in neurosurgery where dissection, fragmentation, emulsification and aspiration of soft tissue are desirable. This system consists of the SonoSurg Generator (SonoSurg-G2 set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducer (SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source. Do not use this system for any purpose other than its intended use.

Source page: https://510kreport.com/device/K041566
Methodology: https://510kreport.com/methodology