Innerdyne Step Trocar Expandable Port

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Innerdyne Step Trocar Expandable Port, Step

510(k) Number

K950632 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Innerdyne Step Trocar Expandable Port, Step

  Class II

  FDA 510(k) K950658 Active Cleared 12 May 1995

• Innerdyne Radially Expanding Vascular Access System (Revas)

  Class II

  FDA 510(k) K992668 Active Cleared 26 May 2000

• Innerdyne Step Trocar Expandable Port, Onestep Open recall

  Class II

  FDA 510(k) K961940 Active Cleared 10 Jul 1996

• Innerdyne Generic Radially Expanding Dilation, G-Red Device

  Class II

  FDA 510(k) K990493 Active Cleared 18 May 1999

• Innerdyne Radially Expanding Vascular Access System

  Class II

  FDA 510(k) K972684 Active Cleared 10 Oct 1997

• Sherwood Medical Company, Kangaroo, Entristar, Percutaneous Gastrostomy Kit

  Class II

  FDA 510(k) K971230 Active Cleared 13 Jun 1997

See all devices from Innerdyne, Inc. →

• What is the primary function of the Innerdyne Step Trocar Expandable Port?

  This surgical instrument is designed to provide dilation access during laparoscopic procedures. It functions by establishing a port of entry to facilitate diagnostic or surgical interventions within the patient.

• What is the regulatory status of this device?

  The Innerdyne Step Trocar Expandable Port has been cleared through the FDA 510(k) Traditional pathway. It is classified as a Class 2 General and Plastic Surgery device under product code GCJ.

• Which medical specialties is this trocar associated with?

  According to the advisory committee documentation for this device, it is associated with Gastroenterology and Urology, reflecting the clinical areas where this type of laparoscopic access is typically utilized.