# K012028: Alliger Ultrasonic Surgical System Model Auss-5

- Pathway: 510(k) (Special)
- Applicant: Misonix, Inc.
- Decided: Jul 27, 2001 after 29 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
No predicates in its family tree.
18 later devices descend from it; 2 cite it directly.
0 of 19 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) Alliger Ultrasonic Surgical System model AUSS-4: named in the summary without a submission number
- (no number) Cavitron Ultrasonic Surgical Aspirator (CUSA) Model NS-100 Ultrasonic Surgical Aspirator: named in the summary without a submission number

## Most influential descendants
- K050776: Auss-6 Ultrasonic Surgical Aspirator System (2005), 17 descendants of its own
- K070313: Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System (2007), 8 descendants of its own
- K062471: Ultrasonic Surgical Aspirator System, Model FS 1000 RF (2006), 6 descendants of its own
- K062544: AR1000 Ultrasonic Wound Therapy System (2007), 5 descendants of its own
- K153743: Piezosurgery Plus (2016), 2 descendants of its own

## Indications for use
The Alliger Ultrasonic Surgical System is indicated for use in the fragmentation and aspiration of both soft and hard (c.g.: bone) tissue in the fallowing surgical specialties: Neurosurgery Gastrointcstinal and Affiliated Organ Surgcry Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthepedic Surgery Gynecology External genitalia ¢ condyloma * benign tumors (lipomas, fibromas, and lciomyomas) » malignent primary and metastabc turnors of all types and the following cystc lesions: » Bartholin’s cysts » Vestibular adenitis » Inclusion cysts » Sebaceous cysts Abdominal area e Any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tubc, uterus, or the supporting structures of the uterus. Thoracic Surgery ¢ Limited pulmonary resection such as segmetectomies, nonanatarmical subsegmentectomics, and metastatectomies

Source page: https://510kreport.com/device/K012028
Methodology: https://510kreport.com/methodology