FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERRALESTER
K Number: K020902
·
Decision May 20, 2002
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
6
Review Days
61
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SERRALESTER
- K Number
- K020902
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Serral, S.A. DE C.V.
- Date Received
- March 20, 2002
- Decision Date
- May 20, 2002
- Product Code
- GAT
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAT), ordered by most recent decision date.
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HyperSuture All Green Extension Line
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Meniscus Versaflex
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pre-Sutured Tendon
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ProZip Knotless Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PowerKnot High Strength Sutures
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K020901 | SERRALSILK | Apr 26, 2002 | Substantially Equivalent |
| K020146 | SERRALNYL | Apr 15, 2002 | Substantially Equivalent |
| K020265 | SERRALENE, MODEL CATALOG NO 1S | Mar 8, 2002 | Substantially Equivalent |