FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEM Biover Microvascular Clamps
K Number: K221843
·
Decision Sep 14, 2022
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
4
Review Days
82
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Basic Information
- Device Name
- GEM Biover Microvascular Clamps
- K Number
- K221843
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synovis Micro Companies Alliance, Inc.
- Date Received
- June 24, 2022
- Decision Date
- September 14, 2022
- Product Code
- DXC
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | FDA class 2 | Cardiovascular |
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