Endoscope Reprocessor OER-Elite— 510(k) K201920
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K201920 for Endoscope Reprocessor OER-Elite, Substantially Equivalent on 2020-09-01. 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
- Special
- Location
- Hachioji-Shi, JP
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- K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid
- K173590 — System 83 Plus Washer/Disinfector
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view all- K262079 — 4K Camera Head OLYMPUS CH-S700-08-LB
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- K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)
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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 K201920
K-number listed on FDA's recall record- Z-1898-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
- Z-1899-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
- Z-1900-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
- Z-1901-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
- Z-1902-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
- Z-1903-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
- Z-1904-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
- Z-1905-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
- Z-1906-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
- Z-1907-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
- Z-1908-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
- Z-1909-2026 — OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
- Z-1612-2026 — Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
- Z-0872-2026 — Olympus OER-Elite
- Z-2344-2023 — Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
- Z-0638-2022 — OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201920.
Data sourced from openFDA. This site is unofficial and independent of the FDA.