FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family)
K Number: K202694
·
Decision Jan 14, 2021
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
42
Applicant Total
1
Review Days
120
Basic Information
- Device Name
- Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family)
- K Number
- K202694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4800
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vycor Medical INC.
- Date Received
- September 16, 2020
- Decision Date
- January 14, 2021
- Product Code
- GZT
- 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 |
|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | FDA class 2 | Neurology |
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