510(k) Report

FDA applicant

Advanced Surgical Concepts (Asc)

North Attleboro, MA4 decisions1999–20010 recalls

FDA records 4 decisions for Advanced Surgical Concepts (Asc) (North Attleboro, MA) from 1999 to 2001: 4 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FFO (Retractor, Self-Retaining). 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 Advanced Surgical Concepts (Asc)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Surgical Concepts (Asc) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Surgical Concepts (Asc) 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
  • FFORetractor, Self-Retaining1decision
  • KKXDrape, Surgical, Antimicrobial1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K010711Ecotract Adjustable Wound Protector/RetractorAdvanced Surgical Concepts (Asc) · 20013cite it

What has FDA decided for it lately?

  • K011183Omniport Hand and Instrument Access DeviceAdvanced Surgical Concepts (Asc) · 2001
  • K010711Ecotract Adjustable Wound Protector/RetractorAdvanced Surgical Concepts (Asc) · 2001
  • K002013OmniportAdvanced Surgical Concepts (Asc) · 2000
  • K993544Space-or RetractorAdvanced Surgical Concepts (Asc) · 1999

All 4 as Advanced Surgical Concepts (Asc) →