# K970917: Solos 10MM Operating Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Woodbine Optical Corp.
- Decided: Jun 10, 1997 after 90 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
to allow surgeons to view the interior cavities of the human body under direct vision through the scope for the purpose of performing surgery by general surgeons and thoracic surgeons.

Source page: https://510kreport.com/device/K970917
Methodology: https://510kreport.com/methodology