# K981262: Cusa Excel Ultrasonic Surgical Aspirator System

- Pathway: 510(k) (Traditional)
- Applicant: Valleylab, Inc.
- Decided: Jul 6, 1998 after 90 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884413 (1988). 4 ancestors in all.
89 later devices descend from it; 11 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921251: Cusa System 200C and 200T Ultrasonic Aspirator, Valleylab, Inc. (1992) Summary page 3.
- K931902: Cusa System 200C/T Ultrasonic Aspirator & Access., Valleylab, Inc. (1994) Summary page 3.
- K934628: Cusa (R) Syst 200CT/200T Ultra Aspir Lap/Cem Access, Valleylab, Inc. (1995) Summary page 3.
- K884413: Cusa System 200H Ultrasonic Surgical Aspirator, Valleylab, Inc. (1988) Summary page 3.

## Most influential descendants
- K991791: Sound Vaser System (1999), 49 descendants of its own
- K022051: Soundvaser System (2002), 48 descendants of its own
- K042261: Macropore Puricel Lipoplasty System (2004), 36 descendants of its own
- K072587: Cytori Aft System (2007), 34 descendants of its own
- K051947: Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone (2005), 29 descendants of its own

## Recalls of this device
- Mar 10, 2014 · Class II · Z-1522-2014: Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert.
- Jan 7, 2013 · Class II · Z-0920-2013: There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the
- Oct 14, 2011 · Not classified · Z-1215-2012: A small number of non-conforming CUSA Excel 23 KHz Standard Tip and flue (item Number C4601S) were released for distribution that did not meet Integra's in-process requirements for release. It was dis

## Indications for use
The CUSA EXcel Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft 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, and Thoracoscopic Surgery.

Source page: https://510kreport.com/device/K981262
Methodology: https://510kreport.com/methodology