FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UTC 3mL Medication Cartridge
K Number: K230718
·
Decision Jun 15, 2023
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
47
Applicant Total
2
Review Days
92
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Basic Information
- Device Name
- UTC 3mL Medication Cartridge
- K Number
- K230718
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gilero, LLC
- Date Received
- March 15, 2023
- Decision Date
- June 15, 2023
- Product Code
- MRZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by Gilero, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | May 6, 2021 | Substantially Equivalent |