510(k) Report

FDA applicant

Lsi Solutions

Victor, NY14 decisions1997–20241 recall

FDA records 14 decisions for Lsi Solutions (Victor, NY) from 1997 to 2024: 13 510(k) clearances and 1 De Novo grant. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GAS (Suture, Nonabsorbable, Synthetic, Polyester). Since 2016 its 510(k)s took a median of 294 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Lsi Solutions, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Lsi Solutions’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2010: 12012: 12017: 12020: 22021: 12024: 2
2007high 2 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lsi Solutions by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lsi Solutions’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery5decisions
  • GASSuture, Nonabsorbable, Synthetic, Polyester2decisions
  • SBKArtificial Chordae Tendineae Surgical Replacement System1decision
  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene1decision
  • HEWCuldoscope (And Accessories)1decision
  • ODCEndoscope Channel Accessory1decision

Also: GAT (1), NBY (1), NEW (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 294 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011016Lsi Solutions Flexible Suture Placement Device and Accessories ProductLsi Solutions · 20017cite it
  • K981531Suture Placement Device and AccessoriesLsi Solutions · 19985cite it
  • K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series…Lsi Solutions, Inc. · 20103cite it
  • K024301Lsi Endoscopic External Accessory Channel and Accessories ProductLsi Solutions · 20032cite it
  • K031443Lsi Solutions Suture Quick Load ProductsLsi Solutions · 20032cite it
  • K040232Lsi Sew-Right R Series Suture Placement Device and Access Product Sew-Right SR-5R, Model 020999Lsi Solutions · 20041cites it

What has FDA decided for it lately?

  • DEN230069Mi-CHORD SystemLsi Solutions, Inc. · 2024
  • K222783MD Mattress Suture Placement DeviceLsi Solutions, Inc. · 2024
  • K202551Cor-Knot MicroLsi Solutions, Inc. · 2021
  • K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions · 2020
  • K203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0…Lsi Solutions, Inc. · 2020
  • K163639LS-5 ePTFE SutureLsi Solutions · 2017
  • K111014Lsi Solutions Fornisee System Uterine Manipulator and AccessoriesLsi Solutions, Inc. · 2012
  • K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series…Lsi Solutions, Inc. · 2010

All 8 as Lsi Solutions →All 6 as Lsi Solutions, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K011016ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI…Apr 1, 2005