UTC 3mL Medication Cartridge
FDA 510(k) clearance K230718 · decided 2023-06-15
Clearance details
- K-number
- K230718
- Device name
- UTC 3mL Medication Cartridge
- Applicant
- Gilero, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-03-15
- Decision date
- 2023-06-15
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- MRZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Morrisville, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.