# K061646: Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Jun 27, 2006 after 15 days
- Product code: FBO (Cystourethroscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stryker Urology and Gynecology Hardware System: named in the summary without a submission number

## Indications for use
The Laserscope GDD Cystourethroscope Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological surgery through minimally invasive approach by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: Dilation of the urethra and cold slitting strictures Trans-urethral incision, vaporization, and resection of the prostrate Trans-urethral removal of bladder tumors

Source page: https://510kreport.com/device/K061646
Methodology: https://510kreport.com/methodology