FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Self-Forming Magnet (Flexagon Plus OTOLoc)
K Number: K253550
·
Decision Jan 9, 2026
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
4
Review Days
56
Basic Information
- Device Name
- Self-Forming Magnet (Flexagon Plus OTOLoc)
- K Number
- K253550
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4816
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GI Windows, Inc.
- Date Received
- November 14, 2025
- Decision Date
- January 9, 2026
- Product Code
- SAH
- 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 |
|---|---|---|---|
| SAH | Magnetic Compression Anastomosis System | FDA class 2 | General, Plastic Surgery |
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