FDA Registration
Active
🇺🇸 United States
COR-KNOT® MIS DEVICE KIT
Reg #: 1320468
·
FEI: 3000206455
·
Expires 2025
Products
4
Proprietary Names
21
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- LSI SOLUTIONS INC.
- Registration Number
- 1320468
- FEI Number
- 3000206455
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7796 VICTOR-MENDON RD.
- City
- VICTOR
- State
- NY
- ZIP
- 14564
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100593
Owner / Operator
- Firm Name
- LSI SOLUTIONS, INC.
- Operator Number
- 9025830
- Address
- 7796 VICTOR-MENDON RD., --
- City
- Victor
- State
- NY
- Postal Code
- 14564
- Country
- US
- Correspondent
- Chris Miller
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2010-11-11 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2010-11-11 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2010-11-11 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2010-11-11 |
Proprietary Names
COR-KNOT® MIS DEVICE KIT
COR-KNOT® QUICK LOAD® 6-POUCH
COR-KNOT MINI® COMBO KIT
COR-SUTURE® QUICK LOAD® - 2-0 Polyester, Green, Non-Absorbable
TK® Ti-KNOT® DEVICE
COR-KNOT MINI® DEVICE KIT
COR-KNOT® QUICK LOAD® SINGLES
INTRA-KNOT® QUICK LOAD®
RD180® 5mm THE RUNNING DEVICE®
COR-SUTURE® QUICK LOAD® - 3-0 Polypropylene, Blue, Non-Absorbable
TK® QUICK LOAD®
C1® Depth Limiter
COR-SUTURE® QUICK LOAD® - 2-0 Polyester, White, Non-Absorbable
C1® Device (Straight Shaft)
RD180® SP THE RUNNING DEVICE®
COR-KNOT® MIS COMBO KIT
RD180® 10mm THE RUNNING DEVICE®
RD® QUICK LOAD® SUTURE 0 Polyester, Green
C1® Device (Angled Shaft)
RD® QUICK LOAD® SUTURE 2-0 Polyester, Green
RD® QUICK LOAD® SUTURE 2-0 Polypropylene, Blue
Establishment Types
Manufacture Medical Device