# K212750: Ultrasonic Surgical Aspirator System, Model: XD880B

- Pathway: 510(k) (Special)
- Applicant: Smtp Technology Co., Ltd.
- Decided: Sep 27, 2021 after 28 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: 5 generations back to K884413 (1988). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202299: Ultrasonic Surgical Aspirator System, Smtp Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations: • Neurosurgery • Gastrointestinal and Affiliated Organ Surgery • Urological surgery • Plastic and Reconstructive surgery • General Surgery • Orthopedic Surgery • Gynecological Surgery • Thoracic Surgery • Wound Care • Laparoscopic Surgery • Thoracoscopic Surgery

Source page: https://510kreport.com/device/K212750
Methodology: https://510kreport.com/methodology