Innerdyne Step Trocar Expandable Port, Ministep

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

510(k) Number

K961430 ↗

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 Innerdyne Step Trocar Expandable Port Ministep used for?

  The Ministep is designed for use during minimally invasive surgery to provide temporary dilation access to the abdominal and thoracic cavities, allowing for the passage of diagnostic and operative instruments into these cavities.

• Is the Innerdyne Step Trocar Expandable Port Ministep a single-use device?

  Yes, the Ministep is supplied as a single-use device and is intended for abdominal and thoracic procedures, providing dilatation access for diagnostic and operative purposes.

• What regulatory approval has the Innerdyne Step Trocar Expandable Port Ministep received?

  The device has received FDA 510(k) clearance with the product code GCJ and was found to be substantially equivalent to predicate devices, with clearance granted on May 28, 1996.

• What is the product code for the Innerdyne Step Trocar Expandable Port Ministep?

  The Ministep has the product code GCJ, which was assigned during the FDA 510(k) clearance process that determined it to be substantially equivalent to predicate devices.