# K970754: Innerdyne Step Trocar Expanable Port, Open Step

- Pathway: 510(k) (Traditional)
- Applicant: Innerdyne, Inc.
- Decided: Apr 21, 1997 after 49 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932020 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943253: Innerdyne Step Trocar Expandable Port, S.T.E.P., Innerdyne Medical, Inc. (1994) Summary page 2.
- K940232: Innerdyne Step Trocar Expandable Port, S.T.E.P., Innerdyne Medical, Inc. (1994) Summary page 2.
- K950632: Innerdyne Step Trocar Expandable Port, Step, Innerdyne, Inc. (1995) Summary page 2.
- K950658: Innerdyne Step Trocar Expandable Port, Step:, Innerdyne, Inc. (1995) Summary page 2.
- K932020: Entree Blunt Tip Trocar and Adapter, Core Dynamics, Inc. (1994) Summary page 2.
- K942447: Hasson Open Laparoscopy Cannula, Linvatec Corp. (1994) Summary page 2.
- (no number) Ethicon, ENDOPATH, Blunt-Tip Disposable Surgical Trocar: named in the summary without a submission number
- (no number) United States Surgical Corporation, BLUNTPORT, Disposable VERSAPORT Trocar System for Open Laparoscopy: named in the summary without a submission number
- (no number) Hasson Stable Access Cannula (SAC) of Marlow Surgical Technologies, Inc.: named in the summary without a submission number

## Indications for use
The Step® family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick. The subject Open-Step® device is configured to be used with the open laparoscopic surgical approach.

Source page: https://510kreport.com/device/K970754
Methodology: https://510kreport.com/methodology