Innerdyne Step Trocar Expandable Port, Onestep

• • Ongoing Z-1387-2023 FDA Class II ·initiated 1 Mar 2023

  Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.

510(k) Number

K961940 ↗

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 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

• Innerdyne Radially Expanding Dilation, Red Device

  Class II

  FDA 510(k) K990854 Active Cleared 2 Aug 1999

See all devices from Innerdyne, Inc. →