FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
K Number: K082535
·
Decision Dec 1, 2008
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
3
Review Days
90
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
- COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
- K Number
- K082535
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Devices, A Global Business Unit Covidien
- Date Received
- September 2, 2008
- Decision Date
- December 1, 2008
- 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