FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pre-Sutured Tendon
K Number: K253145
·
Decision Oct 22, 2025
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
7
Review Days
27
Basic Information
- Device Name
- Pre-Sutured Tendon
- K Number
- K253145
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rti Surgical, Inc.
- Date Received
- September 25, 2025
- Decision Date
- October 22, 2025
- Product Code
- GAT
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM | Mar 31, 2014 | Substantially Equivalent |