FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERRALNYL
K Number: K020146
·
Decision Apr 15, 2002
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
56
Applicant Total
6
Review Days
89
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Basic Information
- Device Name
- SERRALNYL
- K Number
- K020146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Serral, S.A. DE C.V.
- Date Received
- January 16, 2002
- Decision Date
- April 15, 2002
- Product Code
- GAR
- 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 |
|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAR), ordered by most recent decision date.
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REXLON, REXSIL
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Other Clearances by Serral, S.A. DE C.V.
| K Number | Device Name | ||
|---|---|---|---|
| K033762 | SERRALAPG | Mar 15, 2004 | Substantially Equivalent |
| K020597 | SERRALGUT | Aug 14, 2002 | Substantially Equivalent |
| K020902 | SERRALESTER | May 20, 2002 | Substantially Equivalent |
| K020901 | SERRALSILK | Apr 26, 2002 | Substantially Equivalent |
| K020265 | SERRALENE, MODEL CATALOG NO 1S | Mar 8, 2002 | Substantially Equivalent |