FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRIME-XV FreezIS DMSO-Free MD
K Number: K231804
·
Decision Nov 9, 2023
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
8
Applicant Total
4
Review Days
142
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Basic Information
- Device Name
- PRIME-XV FreezIS DMSO-Free MD
- K Number
- K231804
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 876.5885
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujifilm Irvine Scientific
- Date Received
- June 20, 2023
- Decision Date
- November 9, 2023
- Product Code
- NDS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| NDS | Media, Culture, Ex Vivo, Tissue And Cell | FDA class 2 | Gastroenterology, Urology |
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