510(k) Report

FDA applicant

T. Korossurgical Instruments Corp.

Moorepark, CA27 decisions1985–20010 recalls

FDA records 27 decisions for T. Korossurgical Instruments Corp. (Moorepark, CA) from 1985 to 2001: 27 510(k) clearances. Most are in product codes GAD (Retractor) and HRX (Arthroscope). 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, general and plastic surgery panel, where it files most

How often FDA has decided T. Korossurgical Instruments Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for T. Korossurgical Instruments Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — T. Korossurgical Instruments Corp. 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?

  • GADRetractor8decisions
  • HRXArthroscope4decisions
  • GCJLaparoscope, General & Plastic Surgery3decisions
  • GZTRetractor, Self-Retaining, For Neurosurgery2decisions
  • FZSCurette, Surgical, General Use1decision
  • MABMarker, Cardiopulmonary Bypass (Vein Marker)1decision

Also: DXC (1), KIJ (1), KWP (1), BWN (1), FWW (1), LRN (1).

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.

  • K935529Cervical Self-Retaining RetractorT. Korossurgical Instruments Corp. · 19942cite it

What has FDA decided for it lately?

  • K001915Graft Marker RingT. Korossurgical Instruments Corp. · 2001
  • K002755Non-Absorbing Sternatomy Monofilament SutureT. Korossurgical Instruments Corp. · 2000
  • K954016Videoscope W/Irrigation SheathT. Korossurgical Instruments Corp. · 1996
  • K953998Discetome Tissue AspiratorT. Korossurgical Instruments Corp. · 1995
  • K954052Arthroscopic Grasper, Cup Forceps and CurettesT. Korossurgical Instruments Corp. · 1995
  • K954014Percutaneous Discectomy Cannula SystemT. Korossurgical Instruments Corp. · 1995
  • K935529Cervical Self-Retaining RetractorT. Korossurgical Instruments Corp. · 1994
  • K926583Reusable Endoscopic Scissors, Grasper-MonopolarT. Korossurgical Instruments Corp. · 1993

All 27 as T. Korossurgical Instruments Corp. →