# Lsi Solutions

- Location (FDA's records): Victor, NY
- FDA decisions: 14 (1997–2024): 13 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Lsi Solutions (8); Lsi Solutions, Inc. (6)
- Product codes: GCJ (5), GAS (2), SBK (1), GAW (1), HEW (1), ODC (1), GAT (1), NBY (1), NEW (1)
- 510(k) review time since 2016: median 294 days, against 116 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 18 (9 its own); citations of its devices by later devices: 20 (9 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coalescent Surgical: 1 (https://510kreport.com/company/coalescent-surgical)
- CooperSurgical, Inc.: 1 (https://510kreport.com/company/coopersurgical)
- Lsi Soultions: 1 (https://510kreport.com/company/lsi-soultions)
- Deknatel, Inc.: 1 (https://510kreport.com/company/deknatel)
- Samyang Corp.: 1 (https://510kreport.com/company/samyang)
- Cp Medical: 1 (https://510kreport.com/company/cp-medical)
- Sony Medical Electronics Co.: 1 (https://510kreport.com/company/sony-medical-electronics)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)

## Firms that cite its devices most
- Ethicon Endo-Surgery, Inc.: 3 (https://510kreport.com/company/ethicon-endo-surgery)
- Edwards Lifesciences, LLC: 2 (https://510kreport.com/company/edwards-lifesciences)
- Endogastric Solutions, Inc.: 1 (https://510kreport.com/company/endogastric-solutions)
- Byrne Medical, Inc.: 1 (https://510kreport.com/company/byrne-medical)
- Lsi Soultions: 1 (https://510kreport.com/company/lsi-soultions)
- Origami Surgical, LLC: 1 (https://510kreport.com/company/origami-surgical)
- Barosense, Inc.: 1 (https://510kreport.com/company/barosense)
- Neat Stitch, Ltd.: 1 (https://510kreport.com/company/neat-stitch)

## Its most-cited devices
- K011016: Lsi Solutions Flexible Suture Placement Device and Accessories Product (2001), cited by 7
- K981531: Suture Placement Device and Accessories (1998), cited by 5
- K100593: Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme (2010), cited by 3
- K024301: Lsi Endoscopic External Accessory Channel and Accessories Product (2003), cited by 2
- K031443: Lsi Solutions Suture Quick Load Products (2003), cited by 2
- K040232: Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999 (2004), cited by 1

## Recent decisions
- DEN230069: Mi-CHORD System (Jun 11, 2024)
- K222783: MD Mattress Suture Placement Device (Jan 12, 2024)
- K202551: Cor-Knot Micro (Jun 24, 2021)
- K203081: RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture (Nov 24, 2020)
- K203120: RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene (Nov 24, 2020)
- K163639: LS-5 ePTFE Suture (Jun 2, 2017)
- K111014: Lsi Solutions Fornisee System Uterine Manipulator and Accessories (Jul 13, 2012)
- K100593: Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme (Oct 13, 2010)

Source page: https://510kreport.com/company/lsi-solutions