FUJIFILM Distal End Cap— 510(k) K203028
Substantially EquivalentFujifilm Corporation
FDA 510(k) clearance K203028 for FUJIFILM Distal End Cap, Substantially Equivalent on 2020-10-30. Applicant: Fujifilm Corporation. Device class: 2.
Clearance details
- Applicant
- Fujifilm Corporation
- Product code
- Code FDT
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ashigara Kami-Gun, JP
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- K251867 — EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)
- K250701 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
- K233942 — PENTAX Medical Video Duodenoscope (ED34-i10T2s) +3 more
More clearances from Fujifilm Corporation
view allAdverse events under product code FDT
product code FDT- Death
- 86
- Injury
- 1,954
- Malfunction
- 14,912
- Total
- 16,952
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.