MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM— 510(k) K090210
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K090210 for MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM, Substantially Equivalent on 2009-07-29. Applicant: Olympus Medical Systems Corporation.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code NEZ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Center Valley, PA, US
Adverse events under product code NEZ
product code NEZ- Death
- 11
- Injury
- 218
- Total
- 229
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.