FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
TroClose 1200
K Number: K253620
·
Decision Dec 16, 2025
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
3
Review Days
28
Basic Information
- Device Name
- TroClose 1200
- K Number
- K253620
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gordian Surgical, Ltd.
- Date Received
- November 18, 2025
- Decision Date
- December 16, 2025
- Product Code
- GAM
- 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
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