# K110686: Accutrac

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 28, 2011 after 17 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936109 (1994). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082928: Straight Fire Holmium Laser Fiber, Boston Scientific Corp (2008) Summary page 1.
- K100078: Modified Straight Fire Laser Fiber, Boston Scientific Corp (2010) Summary page 1.

## Indications for use
The AccuTrac Laser Fibers are intended for use in laser-based surgical applications, including, but not limited to, endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue. The AccuTrac Laser Fibers are designed for use with Ho:YAG lasers with a standard SMA-905 connector that have been cleared for surgical use.

Source page: https://510kreport.com/device/K110686
Methodology: https://510kreport.com/methodology