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
Suture, Nonabsorbable, Synthetic, Polypropylene GAW
Suture, Nonabsorbable, Synthetic, Polyester GAS
Laparoscope, General & Plastic Surgery GCJ
Guide, Needle, Surgical GDF
Hysteroscope Accessories NWW
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Instrument, Ligature Passing And Knot Tying HCF
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY
Retractor GAD
Instruments, Surgical, Cardiovascular DWS
Holder, Camera, Surgical FXR
Retention Device, Suture KGS
Sound, Urethral, Metal Or Plastic FBX
Artificial Chordae Tendineae Surgical Replacement System SBK
Cannula, Manipulator/Injector, Uterine LKF
Culdoscope (And Accessories) HEW
Cannula, Surgical, General & Plastic Surgery GEA
Instrument, Manual, Surgical, General Use MDM
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Suture, Surgical, Absorbable, Polydioxanone NEW

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