ENDOSCOPE REPROCESSOR OER-MINI— 510(k) K120357
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K120357 for ENDOSCOPE REPROCESSOR OER-MINI, Substantially Equivalent on 2012-12-20. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code FEB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
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- K201920 — Endoscope Reprocessor OER-Elite
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- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)
- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
Adverse events under product code FEB
product code FEB- Malfunction
- 3,879
- Total
- 3,879
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 K120357
K-number listed on FDA's recall record- Z-0874-2026 — Olympus OER-Mini
- Z-2343-2023 — Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120357.
Data sourced from openFDA. This site is unofficial and independent of the FDA.