FDA.reportPublic FDA data

LSI SOLUTIONS INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13204683000206455LSI SOLUTIONS INC.1N2026-01-017796 VICTOR-MENDON RD. VICTOR NY US 14564

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850012846246MD™ QUICK LOAD® - "MD™ QUICK LOAD® SUTURE (2-0 Polyester, Green, Non-absorbable, 38"") with Needle Cap Unloader"+1(866)575-3493regulatorydpt@lsisolutions.com
00850012846529RD® QUICK LOAD® - RD® QUICK LOAD® SUTURE, 2-0 MONOGLIDE® DUO+1(866)575-3493regulatorydpt@lsisolutions.com
00850012846543RAM® COR-SUTURE® QUICK LOAD® - RAM® COR-SUTURE® QUICK LOAD® 6-TRAY 5MM NON-PLGT 2-0 POLYESTER, (3) GREEN and (3) WHITE+1(866)575-3493regulatorydpt@lsisolutions.com
00850012846703PicoDriver - PicoDriver Device Straight+1(866)575-3493regulatorydpt@lsisolutions.com
00850200006148RD® QUICK LOAD® - "RD® QUICK LOAD® SURGICAL SUTURE, 2-0 POLYESTER, NON-ABSORBABLE, 53"", GREEN, BRAIDED"+1(866)575-3493regulatorydpt@lsisolutions.com
00850200006346COR-SUTURE® QUICK LOAD® - "COR-SUTURE® QUICK LOAD® SURGICAL SUTURE, 2-0 POLYESTER WHITE, NON-ABSORBABLE, 38"""+1(866)575-3493regulatorydpt@lsisolutions.com
00850200006353COR-SUTURE® QUICK LOAD® - "COR-SUTURE® QUICK LOAD® SURGICAL SUTURE, 2-0 POLYESTER GREEN, NON-ABSORBABLE, 38"""+1(866)575-3493regulatorydpt@lsisolutions.com
00850200006407RAM® COR-SUTURE® QUICK LOAD® - "RAM® COR-SUTURE® QUICK LOAD® 6-TRAY 3.5MM, PLEDGETED 2-0 POLYESTER, GREEN (3) and WHITE (3), NON-ABSORBABLE, 38"""+1(866)575-3493regulatorydpt@lsisolutions.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
164281455236744K981531SUTURE PLACEMENT DEVICE AND ACCESSORIESGCJ1998-07-13
164281189513249K222783MD Mattress Suture Placement DeviceGCJ2024-01-12
164281786451322K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 PolypropyleneGAS2020-11-24
164281465770411K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureGAS2020-11-24
164281304581598K202551Cor-Knot MicroGCJ2021-06-24
164281807225134K163639LS-5 ePTFE SutureNBY2017-06-02
164281298492535K160529Pledgeted COR-SUTURE QUICK LOADGAW2016-09-15
164281738157891K111014LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIESHEW2012-07-13
164282063554086K100593SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEMEGAW2010-10-13
164281634773611K040232LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999GAT2004-03-01
164281867778871K031443LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTSNEW2003-06-18
164282071393533DEN230069Mi-CHORD SystemSBK2024-06-11
164281554132797
164281109757610
164281112384298
164281373267835
164281651236642
164281697203518
164281704213925
164281850236426
164282022740833

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ32024-01-12
GAS22020-11-24
GAW22016-09-15
SBK12024-06-11
NBY12017-06-02
HEW12012-07-13
GAT12004-03-01
NEW12003-06-18

PMN#

GUDID#

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