ProSeal™ Transfer Injector (421120, 421130, 421140)
FDA 510(k) clearance K251722 · decided 2025-12-05
Clearance details
- K-number
- K251722
- Device name
- ProSeal™ Transfer Injector (421120, 421130, 421140)
- Applicant
- Epic Medical Pte. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-04
- Decision date
- 2025-12-05
- Days to decision
- 184 days
- Clearance type
- Special
- Product code
- ONB
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Singapore, SG
- 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.