FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-REPAIRSL
K Number: K141499
·
Decision Jul 2, 2014
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
2
Review Days
26
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Basic Information
- Device Name
- X-REPAIRSL
- K Number
- K141499
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthasome, Inc.
- Date Received
- June 6, 2014
- Decision Date
- July 2, 2014
- Product Code
- FTL
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Synthasome, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K083307 | SYNTHASOME X-REPAIR | Mar 27, 2009 | Substantially Equivalent |