# K110685: Flexiva Tractip

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 29, 2011 after 18 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.
2 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100078: Modified Straight Fire Laser Fiber, Boston Scientific Corp (2010)

## Most influential descendants
- K210925: Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber,  Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber (2021), 1 descendant of its own
- K251759: Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers (2025), 0 descendants of its own

## Indications for use
The Flexiva™ TracTip Laser Fibers are designed for use with Ho:YAG and Nd:YAG lasers for indications that are cleared for these laser systems, including, but not limited to endoscopic, laparoseopic, and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection, incision of soft and cartilaginous tissue, and fragmentation of urinary and biliary calculi (Ho:YAG wavelength only). The fiber is designed for use with a standard SMA-905 connector that have been cleared for surgical use.

Source page: https://510kreport.com/device/K110685
Methodology: https://510kreport.com/methodology