# K082813: Stryker Led Lightsource

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Dec 19, 2008 after 86 days
- Product code: FCW (Light Source, Fiberoptic, Routine)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961971 (1996). 1 ancestor in all.
27 later devices descend from it; 6 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961971: Q-5000, Stryker Endoscopy (1996) Summary page 1.

## Most influential descendants
- K142922: SpyGlass DS Direct Visualization System (2015), 9 descendants of its own
- K181439: SpyGlass DS and DS II Direct Visualization System (2018), 7 descendants of its own
- K101734: Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera Handpiece; Visionscope Endoscopes (2010), 7 descendants of its own
- K153606: LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application (2016), 6 descendants of its own
- K093792: Led Light Source (2010), 6 descendants of its own

## Recalls of this device
- Mar 2, 2023 · Class II · Z-1474-2023: Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.

## Indications for use
The Stryker LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope. The light source is an integral component of a visualization system which consists of a video camera, video monitor, video recorder, video printer, light cable and scope.

Source page: https://510kreport.com/device/K082813
Methodology: https://510kreport.com/methodology