FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
K Number: K203120
·
Decision Nov 24, 2020
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
16
Applicant Total
3
Review Days
39
Basic Information
- Device Name
- RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
- K Number
- K203120
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LSI Solutions, Inc.
- Date Received
- October 16, 2020
- Decision Date
- November 24, 2020
- Product Code
- GAS
- 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 |
|---|---|---|---|
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAS), ordered by most recent decision date.
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARTHREX BIOWIRE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MR-III
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUTURE CORD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BRAIDED POLYESTER SUTURE MATERIAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PETERS CARDIOFLON(TM) SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery