200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM— 510(k) K944759
Substantially EquivalentFujinon, Inc.
FDA 510(k) clearance K944759 for 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM, Substantially Equivalent on 1995-04-11. Applicant: Fujinon, Inc.. Device class: 2.
Clearance details
- Applicant
- Fujinon, Inc.
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayne, NJ, US
Recent devices under product code FET
view allMore clearances from Fujinon, Inc.
view allAdverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K944759
K-number listed on FDA's recall record- Z-1861-2016 — Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
- Z-1862-2016 — Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
- Z-0418-2016 — Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
- Z-2805-2015 — Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
- Z-2806-2015 — Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944759.
Data sourced from openFDA. This site is unofficial and independent of the FDA.