Extension Feeding Set with ENFit™ Connectors
FDA 510(k) clearance K250481 · decided 2025-04-18
Clearance details
- K-number
- K250481
- Device name
- Extension Feeding Set with ENFit™ Connectors
- Applicant
- SKY Medical, a.s.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-19
- Decision date
- 2025-04-18
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- PIF
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Samorin, SK
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.