ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO— 510(k) K103264
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K103264 for ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO, Substantially Equivalent on 2011-02-23. Applicant: Olympus Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- 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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- K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
- K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
- K213833 — SCOPE BUDDY PLUS Endoscope Flushing Aid
- K201920 — Endoscope Reprocessor OER-Elite
More clearances from Olympus Medical Systems Corporation
view all- K260401 — EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500
- K260856 — Disposable Distal Attachment D-201-13404
- K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- K261260 — HD Camera Head OLYMPUS CH-S200-08-LB
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 K103264
K-number listed on FDA's recall record- Z-1613-2026 — Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
- Z-0873-2026 — Olympus OER-Pro
- Z-1009-2024 — Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
- Z-2447-2023 — The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5
- Z-2342-2023 — Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
- Z-0138-2017 — OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103264.
Data sourced from openFDA. This site is unofficial and independent of the FDA.