510(k) Report

FDA applicant

Surgical Image Laboratories, Inc.

Deerfield Beach, FL2 decisions1996–20000 recalls

FDA records 2 decisions for Surgical Image Laboratories, Inc. (Deerfield Beach, FL) from 1996 to 2000: 2 510(k) clearances. All are in product code GCJ (Laparoscope, General & Plastic Surgery). No recall is linked to its devices.

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 Surgical Image Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgical Image Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K955845LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod LensSurgical Image Laboratories, Inc. · 19961cites it
  • K0015943.5 MM Laparoscope (LG100, LG103)Surgical Image Laboratories, Inc. · 20001cites it

What has FDA decided for it lately?

  • K0015943.5 MM Laparoscope (LG100, LG103)Surgical Image Laboratories, Inc. · 2000
  • K955845LL 100, 103, 104 Diagnostic Laparoscope Rigid Rod LensSurgical Image Laboratories, Inc. · 1996

All 2 as Surgical Image Laboratories, Inc. →