FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE— 510(k) K961974
Substantially EquivalentPentax Precision Instrument Corp.
FDA 510(k) clearance K961974 for FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE, Substantially Equivalent on 1997-02-10. 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
- Miramar, FL, 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 K961974
K-number listed on FDA's recall record- Z-2077-2016 — Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric
- Z-2279-2016 — Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961974.
Data sourced from openFDA. This site is unofficial and independent of the FDA.