Home › FUJIFILM CORPORATION › FUJIFILM
FUJIFILM
FUJIFILM CORPORATION · Model ES-530WE · UDI-DI 04547410333299
1
510(k) clearances
54
Adverse events
2
Recalls
25
Facilities
Description
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-04-06 | Pentax Medical Company | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the U |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.