FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ActivSight Intraoperative Imaging System
K Number: K231344
·
Decision Aug 2, 2023
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
53
Applicant Total
1
Review Days
85
Basic Information
- Device Name
- ActivSight Intraoperative Imaging System
- K Number
- K231344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Activ Surgical Inc.
- Date Received
- May 9, 2023
- Decision Date
- August 2, 2023
- Product Code
- OWN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OWN | Confocal Optical Imaging | FDA class 2 | Gastroenterology, Urology |
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