FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VereSee Optical Veres Needle System
K Number: K232464
·
Decision May 2, 2024
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
176
Applicant Total
2
Review Days
261
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Basic Information
- Device Name
- VereSee Optical Veres Needle System
- K Number
- K232464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1730
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Freyja Healthcare, LLC
- Date Received
- August 15, 2023
- Decision Date
- May 2, 2024
- Product Code
- HIF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Freyja Healthcare, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K252640 | VereSee Optical Veres Needle and Endoscopic Camera | Oct 20, 2025 | Substantially Equivalent |