Single Use Balloon Dilator V (with Knife)— 510(k) K150142
Substantially EquivalentOlympus Medical Systems Corp.
FDA 510(k) clearance K150142 for Single Use Balloon Dilator V (with Knife), Substantially Equivalent on 2015-10-08. Applicant: Olympus Medical Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Olympus Medical Systems Corp.
- Product code
- Code KNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hachioji-Shi, JP
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Adverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
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.