EnteraLoc Flow— 510(k) K223683
Substantially EquivalentVonco Products
FDA 510(k) clearance K223683 for EnteraLoc Flow, Substantially Equivalent on 2023-07-10. Applicant: Vonco Products.
Clearance details
- Applicant
- Vonco Products
- Product code
- Code PIF
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trevor, WI, US
Adverse events under product code PIF
product code PIF- Death
- 13
- Injury
- 122
- Other
- 1
- Total
- 136
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.