OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE— 510(k) K032092
Substantially EquivalentOlympus Optical Co., Ltd.
FDA 510(k) clearance K032092 for OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE, Substantially Equivalent on 2003-07-16. Applicant: Olympus Optical Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Olympus Optical Co., Ltd.
- Product code
- Code FCL
- Device class
- Class 1
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nishitama-Gun Tokyo, JP
Recent devices under product code FCL
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- K024138 — HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE
Adverse events under product code FCL
product code FCL- Death
- 5
- Total
- 5
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.