DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE— 510(k) K000646
Substantially EquivalentEnteric Medical Technologies
FDA 510(k) clearance K000646 for DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE, Substantially Equivalent on 2000-04-13. Applicant: Enteric Medical Technologies.
Clearance details
- Applicant
- Enteric Medical Technologies
- Product code
- Code FBK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster City, CA, US
Adverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
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.