510(k) Report

FDA applicant

Advanced Surgical Intervention, Inc.

San Clemente, CA9 decisions1988–19960 recalls

FDA records 9 decisions for Advanced Surgical Intervention, Inc. (San Clemente, CA) from 1988 to 1996: 9 510(k) clearances. Most are in product codes KOE (Dilator, Urethral) and GEX (Powered Laser Surgical Instrument). 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 Intervention, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Surgical Intervention, 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?

  • KOEDilator, Urethral2decisions
  • GEXPowered Laser Surgical Instrument2decisions
  • FAJCystoscope And Accessories, Flexible/Rigid1decision
  • GBMCatheter, Urethral1decision
  • GCJLaparoscope, General & Plastic Surgery1decision
  • KOBCatheter, Suprapubic (And Accessories)1decision

Also: MNG (1).

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K954215MiniguardAdvanced Surgical Intervention, Inc. · 19961cites it

What has FDA decided for it lately?

  • K954215MiniguardAdvanced Surgical Intervention, Inc. · 1996
  • K926110Asi Ligasure (TM) Suture Ligation InstrumentAdvanced Surgical Intervention, Inc. · 1993
  • K930361Asi Cystolase Laser CystoscopeAdvanced Surgical Intervention, Inc. · 1993
  • K921990Asi Uroplasty Laser CystoscopeAdvanced Surgical Intervention, Inc. · 1992
  • K902585Uroplasty Tcu Prostatic Urethroplasty CatheterAdvanced Surgical Intervention, Inc. · 1990
  • K901336Asi Hemostasis CatheterAdvanced Surgical Intervention, Inc. · 1990
  • K896713Asi Tcu Prostatic Urethroplasty Catheter & Access.Advanced Surgical Intervention, Inc. · 1990
  • K895182Asi Cystoscope Sheath, Grasping Forceps & for.BodyAdvanced Surgical Intervention, Inc. · 1989

All 9 as Advanced Surgical Intervention, Inc. →