# K032339: Cardiovations Portable Video System

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Aug 8, 2003 after 10 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) Karl Storz Endoscopy Endovision Telecam SL: named in the summary without a submission number

## Indications for use
The CardioVations Portable Video System is designed to be used as an accessory in any endoscopic procedures that require a viewing distance up to 2 inches (5cm), when used with many rigid B-style (32mm diameter eyecup) endoscopes.

Source page: https://510kreport.com/device/K032339
Methodology: https://510kreport.com/methodology