FG-36UX FIBER ULTRASOUND GASTROSCOPE— 510(k) K041396
Substantially EquivalentPentax Precision Instrument Corp.
FDA 510(k) clearance K041396 for FG-36UX FIBER ULTRASOUND GASTROSCOPE, Substantially Equivalent on 2004-06-09. Applicant: Pentax Precision Instrument Corp.. Device class: 2.
Clearance details
- Applicant
- Pentax Precision Instrument Corp.
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
Recent devices under product code ITX
view allMore clearances from Pentax Precision Instrument Corp.
view allAdverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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 K041396
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 K041396.
Data sourced from openFDA. This site is unofficial and independent of the FDA.