Enteral Drainage System, Enteral Medicine straw— 510(k) K242917
Substantially EquivalentHMC Premedical S.p.A.
FDA 510(k) clearance K242917 for Enteral Drainage System, Enteral Medicine straw, Substantially Equivalent on 2025-06-18. Applicant: HMC Premedical S.p.A..
Clearance details
- Applicant
- HMC Premedical S.p.A.
- Product code
- Code PIF
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mirandola, IT
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.