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Lsi Solutions Inc.: FDA-registered device maker in Victor, NY, United States, 12 510(k) clearances

Name: Lsi Solutions Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Lsi Solutions Inc. is registered with the FDA (registration 1320468) in Victor, NY, United States. It lists 20 device types. The FDA files 12 510(k) clearances under its listings, the newest dated June 11, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1320468
FEI number: 3000206455
Address: 7796 Victor-Mendon RD., Victor, NY, United States, 14564
Owner or operator: LSI SOLUTIONS, INC. (9025830)
Roles: Manufacturer
First device listed: January 15, 2008
Registered through: 2027
Brand names listed: 3D® MINI ACCESS PORTAL, A-GLIDE OF-25 Axial Soft Tissue Retractor, AVR NAVIGATOR, LARGE RETRACTOR WITH DELIVERY DEVICE, AVR NAVIGATOR, MEDIUM RETRACTOR WITH DELIVERY DEVICE, AVR NAVIGATOR, SMALL RETRACTOR WITH DELIVERY DEVICE, AnastoPod® DEVICE, BOBsnare Device, C1® Depth Limiter and more

Devices it lists

Device	Product code	Class	Role	Source
Artificial Chordae Tendineae Surgical Replacement System	SBK	2	Manufacturer	accessdata.fda.gov
Cannula, Manipulator/Injector, Uterine	LKF	2	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Culdoscope (And Accessories)	HEW	2	Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer	accessdata.fda.gov
Holder, Camera, Surgical	FXR	1	Manufacturer	accessdata.fda.gov
Hysteroscope Accessories	NWW	1	Manufacturer	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Retention Device, Suture	KGS	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Sound, Urethral, Metal Or Plastic	FBX	1	Manufacturer	accessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyester	GAS	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Manufacturer	accessdata.fda.gov
Suture, Surgical, Absorbable, Polydioxanone	NEW	2	Manufacturer	accessdata.fda.gov
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	NBY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 11, 2024	DEN230069	Mi-CHORD System	SBK	Unknown	Lsi Solutions, Inc.	accessdata.fda.gov
January 12, 2024	K222783	MD Mattress Suture Placement Device	GCJ	Substantially Equivalent	Lsi Solutions, Inc.	accessdata.fda.gov
June 24, 2021	K202551	Cor-Knot Micro	GCJ	Substantially Equivalent	Lsi Solutions, Inc.	accessdata.fda.gov
November 24, 2020	K203120	RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene	GAS	Substantially Equivalent	Lsi Solutions, Inc.	accessdata.fda.gov
November 24, 2020	K203081	RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture	GAS	Substantially Equivalent	Lsi Solutions	accessdata.fda.gov
June 2, 2017	K163639	LS-5 ePTFE Suture	NBY	Substantially Equivalent	Lsi Solutions	accessdata.fda.gov
September 15, 2016	K160529	Pledgeted COR-SUTURE QUICK LOAD	GAW	Substantially Equivalent	Lsi Soultions	accessdata.fda.gov
July 13, 2012	K111014	LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES	HEW	Substantially Equivalent	Lsi Solutions, Inc.	accessdata.fda.gov
October 13, 2010	K100593	SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME	GAW	Substantially Equivalent	Lsi Solutions, Inc.	accessdata.fda.gov
March 1, 2004	K040232	LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999	GAT	Substantially Equivalent	Lsi Solutions	accessdata.fda.gov
June 18, 2003	K031443	LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS	NEW	Substantially Equivalent	Lsi Solutions	accessdata.fda.gov
July 13, 1998	K981531	SUTURE PLACEMENT DEVICE AND ACCESSORIES	GCJ	Substantially Equivalent	Lsi Solutions	accessdata.fda.gov

Compare with other makers

Updated June 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.