PENTAX MEDICAL ED-3490TK, Video Duodenoscope— 510(k) K161222
Substantially EquivalentPentax Medical
FDA 510(k) clearance K161222 for PENTAX MEDICAL ED-3490TK, Video Duodenoscope, Substantially Equivalent on 2018-02-07. Applicant: Pentax Medical. Device class: 2.
Clearance details
- Applicant
- Pentax Medical
- 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
- Traditional
- Location
- Montvale, NJ, US
Recent devices under product code FDT
view all- K251861 — FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
- K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315)
- 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 Pentax Medical
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 →
Recalls naming K161222
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161222.
Data sourced from openFDA. This site is unofficial and independent of the FDA.