# K032680: Smith & Nephew 300XL Xenon Light Source-Hermes Ready Model, 7210045

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 26, 2003 after 28 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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) Smith & Nephew 300XL Xenon Illuminator: named in the summary without a submission number

## Indications for use
The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures to provide illumination of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope. The Smith & Nephew Illuminators are indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated endoscope.

Source page: https://510kreport.com/device/K032680
Methodology: https://510kreport.com/methodology