PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P— 510(k) K914008
Substantially EquivalentPentax Precision Instrument Corp.
FDA 510(k) clearance K914008 for PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P, Substantially Equivalent on 1992-01-10. Applicant: Pentax Precision Instrument Corp.. Device class: 2.
Clearance details
- Applicant
- Pentax Precision Instrument Corp.
- Product code
- Code FAJ
- 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
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More clearances from Pentax Precision Instrument Corp.
view allAdverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
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 K914008
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 K914008.
Data sourced from openFDA. This site is unofficial and independent of the FDA.