# K961971: Q-5000

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Jun 28, 1996 after 39 days
- Product code: FSS (Light, Surgical, Floor Standing)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
339 later devices descend from it; 2 cite it directly.
0 of 340 devices 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) Circon-ACMI MV9082 light source: named in the summary without a submission number

## Most influential descendants
- K973700: Hermes Operating Room Control Center (1998), 310 descendants of its own
- K980787: Hermes Operating Room Control Center with the Wom 20L Insufflator (1998), 300 descendants of its own
- K991696: Stryker Hermes-Ready Total Performance System (1999), 253 descendants of its own
- K032117: Stryker Total Performance (TPS) System (2003), 238 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own

## Indications for use
The Stryker Endoscopy Q-5000 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 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 consist of the a video camera, a video monitor, a light cable and a scope.

Source page: https://510kreport.com/device/K961971
Methodology: https://510kreport.com/methodology