Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I— 510(k) K192793
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K192793 for Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I, Substantially Equivalent on 2020-07-17. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code FDF
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
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Adverse events under product code FDF
product code FDF- Death
- 8
- Injury
- 729
- Malfunction
- 61,773
- Total
- 62,510
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 K192793
K-number listed on FDA's recall record- Z-1212-2024 — Colonoscope, Model Number PCF-H190TL.
- Z-1213-2024 — Colonoscope, Model Number PCF-HQ190L.
- Z-0341-2024 — Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL, PCF-S.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192793.
Data sourced from openFDA. This site is unofficial and independent of the FDA.