ENTERIC INJECTION CATHETER WITH IRRIGATION— 510(k) K002778
Substantially EquivalentEnteric Medical Technologies, Inc.
FDA 510(k) clearance K002778 for ENTERIC INJECTION CATHETER WITH IRRIGATION, Substantially Equivalent on 2000-11-22. Applicant: Enteric Medical Technologies, Inc..
Clearance details
- Applicant
- Enteric Medical Technologies, Inc.
- 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.