FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEM ZIPCLIP
K Number: K242541
·
Decision Jan 15, 2025
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
1
Review Days
142
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Basic Information
- Device Name
- GEM ZIPCLIP
- K Number
- K242541
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synovis Micro Companies Alliance A Subsidiary of Baxter Int
- Date Received
- August 26, 2024
- Decision Date
- January 15, 2025
- Product Code
- FZP
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
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