Elemental Granulate
FDA 510(k) clearance K241283 · decided 2025-01-03
Clearance details
- K-number
- K241283
- Device name
- Elemental Granulate
- Applicant
- Zinkh NV
- Decision
- Substantially Equivalent
- Date received
- 2024-05-07
- Decision date
- 2025-01-03
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- OLR
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Gent, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.