510(k) Report

FDA applicant

Advanced Surgical, Inc.

Princeton, NJ21 decisions1992–19950 recalls

FDA records 21 decisions for Advanced Surgical, Inc. (Princeton, NJ) from 1992 to 1995: 21 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and KGX (Tape And Bandage, Adhesive). 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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Surgical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Surgical, 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 Surgery18decisions
  • KGXTape And Bandage, Adhesive1decision
  • DQXWire, Guide, Catheter1decision
  • FMFSyringe, Piston1decision

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.

  • K950126Endoscopic Ligation Device, Ligator Handle, Ligator CartridgeAdvanced Surgical, Inc. · 19951cites it
  • K932540Laporascopic Surgical Instruments /General UseAdvanced Surgical, Inc. · 19941cites it

What has FDA decided for it lately?

  • K950126Endoscopic Ligation Device, Ligator Handle, Ligator CartridgeAdvanced Surgical, Inc. · 1995
  • K950005Trocar Cannula StabilizerAdvanced Surgical, Inc. · 1995
  • K945369Laparoscopic Surgical Instruments for General UseAdvanced Surgical, Inc. · 1994
  • K933497Laparoscopic Covered Surgical RetractorAdvanced Surgical, Inc. · 1994
  • K941500Tissue Isolation and Retrieval BagAdvanced Surgical, Inc. · 1994
  • K931850Verrss Pneumo NeedleAdvanced Surgical, Inc. · 1994
  • K934807Puncture Closure DeviceAdvanced Surgical, Inc. · 1994
  • K932540Laporascopic Surgical Instruments /General UseAdvanced Surgical, Inc. · 1994

All 21 as Advanced Surgical, Inc. →