OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER— 510(k) K010591
Substantially EquivalentOlympus Optical Co., Ltd.
FDA 510(k) clearance K010591 for OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER, Substantially Equivalent on 2001-03-15. Applicant: Olympus Optical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Olympus Optical Co., Ltd.
- Product code
- Code ODG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code ODG
view allMore clearances from Olympus Optical Co., Ltd.
view all- K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
- K031305 — OLYMPUS ULTRASONIC SURGICAL SYSTEM
- K031648 — VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
- K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
- K031347 — ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
Adverse events under product code ODG
product code ODG- Death
- 30
- Injury
- 237
- Malfunction
- 12,387
- Other
- 1
- Total
- 12,655
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 K010591
K-number listed on FDA's recall record- Z-0505-2021 — Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
- Z-0506-2021 — Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010591.
Data sourced from openFDA. This site is unofficial and independent of the FDA.