# K973803: Flexview CO2 Blower with Mist

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Dec 16, 1997 after 71 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- 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 no predicate by number.

## Indications for use
The FlexiView CO, Blower is designed to improve visibility at the anastomotic site or other surgical sites where opaque bodily fluid interferes with visualization. It can be used to assist in anastomoses of tubular structures, such as vessels, nerves, ducts, during procedures such as CABG, MIDCAB, trauma, dialysis access graft procedures, femoral-popliteal, tibial or distal bypasses, and in situ bypass. The FlexiView CO, Blower has application in opea surgical procedures, such as cardiovascular, peripheral vascular, thoracic, general, gynecological, and urological procedures.

Source page: https://510kreport.com/device/K973803
Methodology: https://510kreport.com/methodology