Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1320468

FEI Number

3000206455

Entity Name

LSI SOLUTIONS INC.

City/State/Country

VICTOR, NY, US

Establishment Address

7796 VICTOR-MENDON RD., VICTOR, NY 14564, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LSI SOLUTIONS, INC. (Owner Number: 9025830)

Owner / Operator Contact Address

7796 VICTOR-MENDON RD., --, Victor, NY 14564, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, 2-0 Polyester, White RAM® COR-SUTURE® QUICK LOAD® Singles, Pledgeted - 2-0 Polyester, Green RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, Pledgeted 2-0 Polyester, White RAM® COR-SUTURE® QUICK LOAD® Singles 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 RAM® COR-SUTURE® QUICK LOAD® Singles 2-0 Polyester, White RAM® COR-SUTURE® QUICK LOAD® Singles 2-0 Polyester, Green RAM® COR-SUTURE® QUICK LOAD® Singles, Pledgeted 2-0 Polyester, Green/White Striped COR-SUTURE® QUICK LOAD® - 2-0 Polyester, Green, Non-Absorbable RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, Pledgeted 2-0 Polyester, Green RAM® COR-SUTURE® QUICK LOAD® 6-Tray 5mm, Pledgeted - 2-0 Polyester RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, 2-0 Polyester, Green/White Striped RAM® COR-SUTURE® QUICK LOAD® Singles, Pledgeted - 2-0 Polyester, White RAM® COR-SUTURE® QUICK LOAD® Singles 5mm, Pledgeted 2-0 Polyester, Green/White Striped COR-SUTURE® QUICK LOAD® - 3-0 Polypropylene, Blue, Non-Absorbable COR-SUTURE® QUICK LOAD® - 2-0 Polyester, White, Non-Absorbable 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® COR-SUTURE® QUICK LOAD® - 2-0 Polyester, Green, Non-Absorbable COR-SUTURE® QUICK LOAD® - 3-0 Polypropylene, Blue, Non-Absorbable COR-SUTURE® QUICK LOAD® - 2-0 Polyester, White, Non-Absorbable TK® Ti-KNOT® 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2021-07-16
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2021-07-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-07-13
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-07-07
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2013-07-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-01-15
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2008-01-15
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2017-08-16
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2015-06-22
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2016-10-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-02-06
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2024-02-06
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2016-10-18
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-10-18
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2019-01-25
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2026-01-05
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	2024-04-16
SBK	Artificial Chordae Tendineae Surgical Replacement System	Cardiovascular	Class 2	870.3490	2024-07-08
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2012-08-09
HEW	Culdoscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1640	2012-08-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-15
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-10-18
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2010-11-11
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2010-11-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-11-11
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2010-11-11
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2018-07-03

Official Correspondent

Chris Miller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LSI SOLUTIONS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

Registration Number	Establishment Name	Location
3014772181	APTOS LLC	Tbilisi, GE
3011689956	DYLAN LUCAS INTERNATIONAL INC	Vaughan Ontario, CA
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1320468. Last updated year: 2026. Please use registration number 1320468 when referencing this establishment in official correspondence.