# K980604: Smith & Nephew Dyonics Endoscopes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: May 19, 1998 after 91 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) line of Laparoscopes/Thoracoscopes offered by Karl Storz Endoscopy Telescope for use in thoracic surgical procedures: named in the summary without a submission number

## Indications for use
Dyonics endoscopes are indicated for use in laparoscopic and thoracic surgical procedures to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals.

Source page: https://510kreport.com/device/K980604
Methodology: https://510kreport.com/methodology