FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GraftGun Universal Graft Delivery System (GDS)
K Number: K243580
·
Decision Feb 5, 2025
Classifications
1
FEI Numbers
553
Registration Numbers
553
Same Product Code
738
Applicant Total
1
Review Days
78
Basic Information
- Device Name
- GraftGun Universal Graft Delivery System (GDS)
- K Number
- K243580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SurGenTec, LLC.
- Date Received
- November 19, 2024
- Decision Date
- February 5, 2025
- Product Code
- FMF
- Advisory Committee
- General Hospital
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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