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Innerdyne Step Trocar Expandable Port, Step

by Innerdyne, Inc.

510(k) K950658

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK950658 Date12 May 1995ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Innerdyne Step Trocar Expandable Port, Step is a device intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic and therapeutic interventions. It is designed for use in abdominal or thoracic access during minimally invasive surgery.

This device is supplied as a reusable instrument and is indicated for use in laparoscopic procedures. It received FDA 510(k) clearance under K950658 and is substantially equivalent to predicate devices. The device is manufactured by Innerdyne, Inc. and is authorized for marketing in the United States.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Innerdyne Step Trocar Expandable Port, Step used for?

    It is intended to provide dilation access for laparoscopic procedures to establish a port of entry for diagnostic and therapeutic interventions during abdominal or thoracic minimally invasive surgery.

  • Is the Innerdyne Step Trocar Expandable Port, Step reusable or single-use?

    The device is supplied as a reusable instrument, meaning it is designed for multiple uses after appropriate cleaning and sterilization between procedures.

  • How is the Innerdyne Step Trocar Expandable Port, Step supplied?

    It is supplied as a reusable instrument, requiring reprocessing (cleaning and sterilization) by the healthcare facility prior to each use in laparoscopic procedures.

  • What regulatory pathway was used for the Innerdyne Step Trocar Expandable Port, Step?

    The device received FDA 510(k) clearance under K950658, demonstrating substantial equivalence to predicate devices for laparoscopic access.