# K140503: Flexiva SF Side-Firing Single-Use Laser Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Apr 15, 2014 after 47 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)
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001)
- K100078: Modified Straight Fire Laser Fiber, Boston Scientific Corp (2010) Summary page 1.

## Indications for use
The Flexiva SF Side-Firing Single-Use Laser Fiber is 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, laparoscopic, and open surgical procedures involving vaporization, ablation, coagulation, hernostasis, 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 has been cleared for surgical use.

Source page: https://510kreport.com/device/K140503
Methodology: https://510kreport.com/methodology