# K984434: Medivision Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Medivision Scope Service Center, Inc.
- Decided: Mar 17, 1999 after 93 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
The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic, procedures such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The laparoscope may be attached to hand-held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The laparoscope is designed to pass through standard laparoscopic and thoracoscopic 10mm cannulas to gain access to the subject surgical site.

Source page: https://510kreport.com/device/K984434
Methodology: https://510kreport.com/methodology