# K021989: Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3

- Pathway: 510(k) (Traditional)
- Applicant: Integra Neurosciences
- Decided: Sep 13, 2002 after 87 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K884413 (1988). 7 ancestors in all.
23 later devices descend from it; 5 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)
- K981262: Cusa Excel Ultrasonic Surgical Aspirator System, Valleylab, Inc. (1998) Summary page 1.
- K010637: Sonotome Ultrasonic Aspirator Tips, Synergetics, Inc. (2001)
- K010309: Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator, Mutoh America Co., Ltd. (2001) Summary page 1.

## Most influential descendants
- K071669: Integra Selector Ultrasonic Surgical Aspirator System with Bone Tip (2007), 17 descendants of its own
- K042277: Selector Quantum Ultrasonic Aspirator System (2004), 17 descendants of its own
- K081459: Cusa Selector NXT Ultrasonic Tissue Ablation System (2008), 16 descendants of its own
- K161882: CUSA Clarity Ultrasonic Surgical Aspirator System (2016), 11 descendants of its own
- K182809: CUSA Clarity Ultrasonic Surgical Aspirator System (2018), 10 descendants of its own

## Recalls of this device
- Nov 28, 2005 · Not classified · Z-0431-06: Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues. (2nd recall, same problem see Z-141-6)
- Sep 13, 2005 · Not classified · Z-0141-06: Integra became aware that certain Model 24kHz Neuro Short Sterile tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.

## Indications for use
The SELECTOR@ Integra Ultrasonic 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/K021989
Methodology: https://510kreport.com/methodology