OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE— 510(k) K843084
Substantially EquivalentOlympus Corp.
FDA 510(k) clearance K843084 for OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE, Substantially Equivalent on 1985-01-03. Applicant: Olympus Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Corp.
- Product code
- Code FBO
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Success, NY, US
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- K082046 — KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
- K080780 — ANCHORAGE SCOPE, MODEL 000003
More clearances from Olympus Corp.
view allRecalls naming K843084
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 K843084.
Data sourced from openFDA. This site is unofficial and independent of the FDA.