# K972114: Olympus Sonosurg System

- Pathway: 510(k) (Traditional)
- Applicant: The Olympus Optical Co.
- Decided: May 18, 1998 after 347 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: 2 generations back to K801623 (1980). 9 ancestors in all.
213 later devices descend from it; 8 cite it directly.
4 of 223 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905315: Ultracision Harmonic Scalpel, Ultracision, Inc. (1991) Summary page 1.
- K962952: Olympus Ultrasonic Surgical System (Usu), Olympus Optical, Co. (1996) Summary page 1.
- K925699: Harmonic Scalpel Laparosonic Clamp Coagulator Acc., Ultracision, Inc. (1993) Summary page 1.
- K944201: HI-Q Hand Instruments- Urology, Olympus America, Inc. (1994) Summary page 1.

## Most influential descendants
- 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
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own

## Indications for use
This system is designed to incise and coagulate soft tissue for laparoscopic and intraabdominal procedures in general surgery.

Source page: https://510kreport.com/device/K972114
Methodology: https://510kreport.com/methodology