# K031305: Olympus Ultrasonic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Sep 23, 2003 after 152 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: 3 generations back to K801623 (1980). 12 ancestors in all.
26 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012176: Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models DH105, DH145, SH105, SH145, Ethicon Endo-Surgery, Inc. (2001)
- K972114: Olympus Sonosurg System, The Olympus Optical Co. (1998) Summary page 1.
- K000095: Olympus Sonosurg Trocar XT3900 System, The Olympus Optical Co. (2000)

## Most influential descendants
- K100597: Harmonic Focus Shears (2010), 18 descendants of its own
- K111202: Surgical Tissue Management System (2012), 11 descendants of its own
- K132703: Thunderbeat (2014), 9 descendants of its own
- K133314: Harmonic Focus Shears + Adaptive Tissue Technology (2013), 9 descendants of its own
- K151743: THUNDERBEAT Open Fine Jaw (2016), 6 descendants of its own

## Indications for use
OLYMPUS Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intrabdominal procedures in general (open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in ENT(Ears, Nose, Throat) surgery.

Source page: https://510kreport.com/device/K031305
Methodology: https://510kreport.com/methodology