# K021929: Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Axya Medical, Inc.
- Decided: Sep 10, 2002 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: 3 generations back to K801623 (1980). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895252: Ultracision Ultrasonic Scalpel, Ultracision, Inc. (1989) Summary page 1.
- K972114: Olympus Sonosurg System, The Olympus Optical Co. (1998) Summary page 1.

## Indications for use
The Axya Model 100 Sonic Scalpel™ Ultrasonic Surgical System is indicated for use in endoscopic and open surgical procedures for the cutting and coagulation of soft tissue structures.

Source page: https://510kreport.com/device/K021929
Methodology: https://510kreport.com/methodology