# K031847: Cardiovations Retractor

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Jul 21, 2003 after 35 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) CardioVations Ultra-Retractor: named in the summary without a submission number

## Indications for use
The CardioVations Retractor has application for use in the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in surgical procedures requiring dissection and retraction of tissue.

Source page: https://510kreport.com/device/K031847
Methodology: https://510kreport.com/methodology