FDA Registration
Active
🇺🇸 United States
LSI SOLUTIONS INC.
Reg #: 1320468
·
FEI: 3000206455
·
Expires 2026
Products
20
Proprietary Names
126
Establishment Types
1
Classifications
20
Registration Details
- Registration Name
- LSI SOLUTIONS INC.
- Registration Number
- 1320468
- FEI Number
- 3000206455
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7796 VICTOR-MENDON RD.
- City
- VICTOR
- State
- NY
- ZIP
- 14564
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203081
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, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2021-07-16 |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2021-07-16 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2021-07-13 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2025-07-07 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2013-07-17 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2008-01-15 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2008-01-15 |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | Class 2 | General, Plastic Surgery | No | 2017-08-16 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2015-06-22 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2016-10-18 |
| Holder, Camera, Surgical | FXR | Class 1 | General, Plastic Surgery | No | 2019-01-25 |
| Retention Device, Suture | KGS | Class 1 | General, Plastic Surgery | No | 2026-01-05 |
| Sound, Urethral, Metal Or Plastic | FBX | Class 1 | Gastroenterology, Urology | No | 2024-04-16 |
| Artificial Chordae Tendineae Surgical Replacement System | SBK | Class 2 | Cardiovascular | No | 2024-07-08 |
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2012-08-09 |
| Culdoscope (And Accessories) | HEW | Class 2 | Obstetrics/Gynecology | No | 2012-08-09 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2016-10-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2018-07-03 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2008-01-15 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2008-01-15 |
Proprietary Names
RAM® COR-SUTURE® QUICK LOAD® 6-Tray 5mm - 2-0 Polyester
RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, Pledgeted 2-0 Polyester, Green/White Striped
RAM® COR-SUTURE® QUICK LOAD® Singles 2-0 Polyester, White
RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, Pledgeted 2-0 Polyester, Green
COR-SUTURE® QUICK LOAD® - 2-0 Polyester, White, Non-Absorbable
RAM® COR-SUTURE® QUICK LOAD® Singles 2-0 Polyester, Green
COR-SUTURE® QUICK LOAD® - 2-0 Polyester, Green, Non-Absorbable
RAM® COR-SUTURE® QUICK LOAD® Singles, Pledgeted - 2-0 Polyester, White
RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, Pledgeted 2-0 Polyester, White
RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, 2-0 Polyester, White
RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, 2-0 Polyester, Green/White Striped
RAM® COR-SUTURE® QUICK LOAD® Singles, Pledgeted - 2-0 Polyester, Green
RAM® COR-SUTURE® QUICK LOAD® Singles 2-0 Polyester, Green/White Striped
RAM® COR-SUTURE® QUICK LOAD® 6-Tray 5mm, Pledgeted - 2-0 Polyester
COR-SUTURE® QUICK LOAD® - 3-0 Polypropylene, Blue, Non-Absorbable
RAM® COR-SUTURE® QUICK LOAD® Singles, Pledgeted 2-0 Polyester, Green/White Striped
RAM® COR-SUTURE® QUICK LOAD® 6-Tray, Pledgeted - 2-0 Polyester
RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, 2-0 Polyester, Green
MD QUICK LOAD® SUTURE
COR-KNOT MICRO®
COR-KNOT MICRO® XL TWIN PACK
COR-KNOT MICRO® TWIN PACK
COR-KNOT MICRO® XL DEVICE KIT
PICODRIVER STRAIGHT DEVICE
PicoDriver Device
PNEUMOSTOP® PLUS DEVICE
PNEUMOSTOP® DEVICE
RD® THE RUNNING DEVICE® Bariatric Length
RD® THE RUNNING DEVICE® Standard Length
LS-5 ePTFE QUICK LOAD® Suture
multiSTATION® ViewSite Retractor
3D® MINI ACCESS PORTAL
miniRUMEL® Device, 25cm
SEW-EASY® Combo Kit, 3.5mm
SEW-EASY® Cassette Singles, 5mm
SEW-EASY® COMBO Kit, 5mm
RAM® RACK
VALVEVAULT® DEVICE (L) 27mm / 29mm
miniRUMEL® Device, 15cm
VALVEVAULT® DEVICE (M) 23mm / 25mm
SEW-EASY® Device Kit, 3.5mm
SEW-EASY® M Device
SEW-EASY® Device Kit, 5mm
RAM® RING
SEW-EASY® SNARE
SEW-EASY® Cassette Singles, 3.5mm
VALVEVAULT® DEVICE (S) 19mm / 21mm
VALVEVAULT® DEVICE KIT (1 each VALVEVAULT® DEVICE (S), (M), (L))
AVR NAVIGATOR, SMALL RETRACTOR WITH DELIVERY DEVICE
AVR NAVIGATOR, LARGE RETRACTOR WITH DELIVERY DEVICE
AVR NAVIGATOR, MEDIUM RETRACTOR WITH DELIVERY DEVICE
C1® Device (Angled Shaft)
MD MATTRESS DEVICE
RAM® Device, 5mm
RAM® Device, 3.5mm
C1® Depth Limiter
C1® Device (Straight Shaft)
VIRTUOSEW Device
multiSTATION® Locking Coupler
SVELTEFELT QUICK PLEDGE UNIT
PROSTAGRIP DEVICE
Mi-CHORD System
FS® SOUND, 8cm
FS® SOUND Set of 4
FS-30 FS® DEVICES
FS-40 FS® DEVICES
FS® SOUND, 12cm
FS® SOUND, 6cm
FS-35 FS® DEVICES
Combo Box of 6 FORNISEE® Devices - 2 each of FS-30, FS-35, FS-40
FS® SOUND, 10cm
TK® Ti-KNOT® QUICK LOAD®
COR-KNOT MESO XL Device
TK® Ti-KNOT® DEVICE
SCOPEPORT
JNW URTRAC® Instrument Guide
COR-KNOT MINI® COMBO KIT
RD180® 5mm THE RUNNING DEVICE®
RD180® 10mm THE RUNNING DEVICE®
RD180® SP THE RUNNING DEVICE®
RD® QUICK LOAD® SUTURE 0 Polyester, Green
RD® QUICK LOAD® SUTURE 2-0 Polyester, Green
TK® QUICK LOAD®
COR-KNOT® QUICK LOAD® 6-POUCH
INTRA-KNOT® QUICK LOAD®
COR-KNOT® MIS DEVICE KIT
COR-KNOT® QUICK LOAD® SINGLES
RD® QUICK LOAD® SUTURE 2-0 Polypropylene, Blue
COR-KNOT MINI® DEVICE KIT
COR-KNOT® MIS COMBO KIT
multiSTATION® duoDOC L RAIL CLAMP
multiSTATION® CLICK RELEASE miniARM®
RAPORT KIT RP-100
multiSTATION® LITA RetroSterno CURVED PADDLE
multiSTATION® RITA RetroSterno FLAT PADDLE
multiSTATION® LITA RetroSterno FLAT PADDLE
multiSTATION® 5mm CANNULA WITH OBTURATOR
AnastoPod® DEVICE
multiSTATION® RITA RetroSterno CURVED PADDLE
RAPORT KIT RP-75
multiSTATION® duoDOC R RAIL CLAMP
multiSTATION® RIGID miniARM®
multiSTATION® triDOC® RAIL CLAMP
multiSTATION® triFLEX CLAMPING ADAPTER
multiSTATION® DOC-X 15 EXTENDER
RAPORT KIT RP-50
multiSTATION® CANNULA ADAPTER
multiSTATION® DOC-X 25 EXTENDER
multiSTATION® BITA RetroSterno PADDLE
multiSTATION® SubX STERNAL ASCENDER SYSTEM
BOBsnare Device
multiSTATION® monoDOC RAIL CLAMP
multiSTATION® DOC-X 45 EXTENDER
A-GLIDE OF-25 Axial Soft Tissue Retractor
multiSTATION® 10mm COUPLER
multiSTATION® ACCESS ADAPTER
multiSTATION® ARTICULATING ADAPTER
multiSTATION® CLAMPING ADAPTER
GENTLEGUIDE DEVICE
RD® QUICK LOAD® SUTURE 2-0 MONOGLIDE® DUO, Purple
RD® QUICK LOAD® SUTURE 0 Polyester, Green
RD® QUICK LOAD® SUTURE 0 MONOGLIDE®, Purple
RD® QUICK LOAD® SUTURE 2-0 STRONGSORB®, Violet
RD® QUICK LOAD® SUTURE 2-0 Polypropylene, Blue
RD® QUICK LOAD® SUTURE 2-0 MONOGLIDE®, Purple
RD® QUICK LOAD® SUTURE 2-0 Polyester, Green
Establishment Types
Manufacture Medical Device