FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Barbed PDO Suture
K Number: K252171
·
Decision Jun 12, 2026
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
63
Applicant Total
1
Review Days
337
Basic Information
- Device Name
- Barbed PDO Suture
- K Number
- K252171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4840
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sutura Medical Technology, Inc.
- Date Received
- July 10, 2025
- Decision Date
- June 12, 2026
- Product Code
- NEW
- 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 |
|---|---|---|---|
| NEW | Suture, Surgical, Absorbable, Polydioxanone | FDA class 2 | General, Plastic Surgery |
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