# K962952: Olympus Ultrasonic Surgical System (Usu)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical, Co.
- Decided: Nov 29, 1996 after 122 days
- Product code: LBK (Neurosurgical Ultrasonic Instruments)
- 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: 1 generation back to K801623 (1980). 5 ancestors in all.
214 later devices descend from it; 3 cite it directly.
4 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801623: Cavitron Ultrasonic Surg. Aspir. Cusa, Cavitron Corp. (1980) Summary page 1.
- K910696: Cusa (R) System 200C/200T/200M/200H Ultra Aspirator, Valleylab, Inc. (1991) Summary page 1.
- K921251: Cusa System 200C and 200T Ultrasonic Aspirator, Valleylab, Inc. (1992) Summary page 1.
- K950945: Cooper Laser Sonics Cusa Model 200, Valleylab, Inc. (1995) Summary page 1.
- K883091: Sharplan 4300 & 4310 Ultrasonic Surgical Apirators, Sharplan Lasers, Inc. (1988) Summary page 1.

## Most influential descendants
- K972114: Olympus Sonosurg System (1998), 213 descendants of its own
- K981993: Olympus Integrated Endosurgery System Endoalpha (1998), 175 descendants of its own
- K994231: Siemens Integrated Operating System (Sios) (2000), 157 descendants of its own
- K052202: Axiom Artis - Modular Angiographic System (2006), 154 descendants of its own
- K061054: Axiom Aristos FX Plus (2006), 80 descendants of its own

## Indications for use
The Olympus Ultrasonic Surgical System is indicated for use in the fragmentation, emulsification, and aspiration of soft tissue in the neurosurgery field.

Source page: https://510kreport.com/device/K962952
Methodology: https://510kreport.com/methodology