PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23— 510(k) K850020
Substantially EquivalentPentax Precision Instrument Corp.
FDA 510(k) clearance K850020 for PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23, Substantially Equivalent on 1985-07-09. Applicant: Pentax Precision Instrument Corp.. Device class: 2.
Clearance details
- Applicant
- Pentax Precision Instrument Corp.
- Product code
- Code FDS
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
Recent devices under product code FDS
view allMore clearances from Pentax Precision Instrument Corp.
view allAdverse events under product code FDS
product code FDS- Death
- 37
- Injury
- 863
- Malfunction
- 56,442
- Other
- 1
- Total
- 57,343
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 K850020
K-number listed on FDA's recall record- Z-2071-2016 — Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
- Z-2290-2014 — PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
- Z-0084-2014 — PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K850020.
Data sourced from openFDA. This site is unofficial and independent of the FDA.