510(k) · Cleared
ClearedFlexview CO2 Blower with Mist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, Inc. · FQH Lavage, Jet
Cleared on Dec 16, 1997 after a 71-day review. The FDA summary names no predicate by number.
- Decided
- Dec 16, 1997
- Review
- 71 days
- Class
- Class II
- Product code
- FQH
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FQH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FQH device
- #1 K253996 BD Surgiphor™ Antimicrobial Irrigation System…score 14.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FQH devicesFQH Lavage, Jet: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FQH
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FQH
410in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FQH
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQH
835in 2025
MAUDE reports naming product code FQH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 13 | 10 |
| 2008 | 0 | — | 0 | 27 |
| 2009 | 3 | 240 | 1 | 70 |
| 2010 | 0 | — | 7 | 135 |
| 2011 | 2 | — | 0 | 83 |
| 2012 | 1 | — | 0 | 133 |
| 2013 | 0 | — | 0 | 134 |
| 2014 | 0 | — | 0 | 194 |
| 2015 | 1 | — | 0 | 116 |
| 2016 | 1 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 243 |
| 2018 | 0 | — | 0 | 317 |
| 2019 | 0 | — | 2 | 328 |
| 2020 | 3 | 130 | 0 | 393 |
| 2021 | 1 | — | 0 | 398 |
| 2022 | 4 | 136 | 0 | 171 |
| 2023 | 3 | 410 | 0 | 333 |
| 2024 | 0 | — | 0 | 425 |
| 2025 | 0 | — | 0 | 835 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973803: Flexview CO2 Blower with Mist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973803
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026