OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS— 510(k) K853585
Substantially EquivalentOlympus Corp.
FDA 510(k) clearance K853585 for OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS, Substantially Equivalent on 1986-01-21. Applicant: Olympus Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Corp.
- 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
- Lake Success, NY, US
Recent devices under product code FET
view allMore clearances from Olympus Corp.
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 K853585
K-number listed on FDA's recall record- Z-2269-2018 — Olympus JF-140F duodenoscopes (Model NumberJF-140F)
- Z-2270-2018 — Olympus JF-160F duodenoscopes (Model NumberJF-160F)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K853585.
Data sourced from openFDA. This site is unofficial and independent of the FDA.