FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
cCeLL - In vivo
K Number: K233391
·
Decision Aug 21, 2024
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
2
Review Days
324
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Basic Information
- Device Name
- cCeLL - In vivo
- K Number
- K233391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VPIX Medical, Inc.
- Date Received
- October 2, 2023
- Decision Date
- August 21, 2024
- Product Code
- GWG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
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Other Clearances by VPIX Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | Feb 13, 2026 | Substantially Equivalent |