# K093691: Accumax

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 11, 2009 after 11 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K153124: DuraLazeTM HoLEP Laser Fiber (2016), 0 descendants of its own

## Indications for use
The Straight Fire Holmium Laser Fiber is indicated for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic 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 Straight Fire Holmium Laser Fiber is designed for use with holmium (H-o:YAG) lasers with a standard LSMA-905 connector that have been cleared for surgical use.

Source page: https://510kreport.com/device/K093691
Methodology: https://510kreport.com/methodology