# K020220: Ultrasonic Straight/Ultrasonic Knife/Ultrasonic Ring Currette

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics, Inc.
- Decided: Aug 23, 2002 after 213 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CUSA Excel Ultrasonic Surgical Aspirator: named in the summary without a submission number

## Most influential descendants
- K051947: Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone (2005), 29 descendants of its own
- K071669: Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip (2007), 17 descendants of its own
- K081459: Cusa Selector NXT Ultrasonic Tissue Ablation System (2008), 16 descendants of its own
- K141668: Cusa Excel+ Ultrasonic Surgical Aspirator System (2014), 14 descendants of its own
- K161882: CUSA Clarity Ultrasonic Surgical Aspirator System (2016), 11 descendants of its own

## Recalls of this device
- Mar 22, 2016 · Class II · Z-1378-2016: The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in the packaging is the incorrect size. Risk to Health: If the Tip Sleeve Assembly does not 

## Indications for use
Synergetics SonotomeTMUltrasonic Aspirator Tips are intended for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including: Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery

Source page: https://510kreport.com/device/K020220
Methodology: https://510kreport.com/methodology