FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
REXLENE
K Number: K173747
·
Decision Dec 21, 2018
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
5
Review Days
378
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
- REXLENE
- K Number
- K173747
- 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
- Sm Eng Co., Ltd.
- Date Received
- December 8, 2017
- Decision Date
- December 21, 2018
- 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