Enteral Drainage System, Enteral Medicine straw
FDA 510(k) clearance K242917 · decided 2025-06-18
Clearance details
- K-number
- K242917
- Device name
- Enteral Drainage System, Enteral Medicine straw
- Applicant
- HMC Premedical S.p.A.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-24
- Decision date
- 2025-06-18
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- PIF
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mirandola, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.