Lsi Solutions Inc.
Victor, NY, US
LSI SOLUTIONS INC. appears in FDA device records in Victor, NY. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Lsi Solutions Inc. between 1997 and 2024. The busiest year on record is 2003, with 2. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2017 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| DEN230069 | Mi-CHORD System | SBK | Unknown | |
| K222783 | MD Mattress Suture Placement Device | GCJ | Substantially Equivalent | |
| K202551 | Cor-Knot Micro | GCJ | Substantially Equivalent | |
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene | GAS | Substantially Equivalent | |
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | GAS | Substantially Equivalent | |
| K163639 | LS-5 ePTFE Suture | NBY | Substantially Equivalent | |
| K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES | HEW | Substantially Equivalent | |
| K100593 | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME | GAW | Substantially Equivalent | |
| K040232 | LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 | GAT | Substantially Equivalent | |
| K031443 | LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS | NEW | Substantially Equivalent | |
| K024301 | LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT | ODC | Substantially Equivalent | |
| K011016 | LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT | GCJ | Substantially Equivalent | |
| K981531 | SUTURE PLACEMENT DEVICE AND ACCESSORIES | GCJ | Substantially Equivalent | |
| K963919 | LSI VIDEOSCOPIC DISPLAY SYSTEM | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1320468 | 3000206455 | LSI SOLUTIONS INC. | 7796 VICTOR-MENDON RD., VICTOR, NY 14564 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- SBKArtificial Chordae Tendineae Surgical Replacement System
- LKFCannula, Manipulator/Injector, Uterine
- GEACannula, Surgical, General & Plastic Surgery
- HEWCuldoscope (And Accessories)
- ODCEndoscope Channel Accessory
- GDFGuide, Needle, Surgical
- FXRHolder, Camera, Surgical
- NWWHysteroscope Accessories
- HCFInstrument, Ligature Passing And Knot Tying
- MDMInstrument, Manual, Surgical, General Use
- DWSInstruments, Surgical, Cardiovascular
- GCJLaparoscope, General & Plastic Surgery
- KGSRetention Device, Suture
- GADRetractor
- FBXSound, Urethral, Metal Or Plastic
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GASSuture, Nonabsorbable, Synthetic, Polyester
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- NEWSuture, Surgical, Absorbable, Polydioxanone
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Lsi Solutions Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain