FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
K Number: K093112
·
Decision Feb 1, 2010
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
4
Review Days
123
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
- DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
- K Number
- K093112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast Manufacturing Us, LLC
- Date Received
- October 1, 2009
- Decision Date
- February 1, 2010
- Product Code
- GAW
- 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAW), ordered by most recent decision date.
STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cypris eXact Suturing System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Non absorbable Surgical Polypropylene Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vesseal
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DURAMESH Mesh Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APTOS Threads Polypropylene Surgical Sutures
FDA 510(k)
FDA Class 2
·General, Plastic Surgery