OLYMPUS BF TYPE UC160-OL8— 510(k) K042140
Substantially EquivalentOlympus Corporation
FDA 510(k) clearance K042140 for OLYMPUS BF TYPE UC160-OL8, Substantially Equivalent on 2004-08-18. Applicant: Olympus Corporation. Device class: 2.
Clearance details
- Applicant
- Olympus Corporation
- 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
- Melville, NY, US
Recent devices under product code ODG
view allMore clearances from Olympus Corporation
view allAdverse 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 K042140
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042140.
Data sourced from openFDA. This site is unofficial and independent of the FDA.