# K961430: Innerdyne Step Trocar Expandable Port, Ministep

- Pathway: 510(k) (Traditional)
- Applicant: Innerdyne, Inc.
- Decided: May 28, 1996 after 43 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 K940232 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 1.
- K940232: Innerdyne Step Trocar Expandable Port, S.T.E.P., Innerdyne Medical, Inc. (1994) Summary page 1.
- K950632: Innerdyne Step Trocar Expandable Port, Step, Innerdyne, Inc. (1995) Summary page 1.
- K950658: Innerdyne Step Trocar Expandable Port, Step:, Innerdyne, Inc. (1995) Summary page 1.
- K943810: Imagyn Microlap Introducer, Imagyn Medical, Inc. (1995) Summary page 1.
- (no number) USSC AutoSuture MiniSite Introducer: 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.

Source page: https://510kreport.com/device/K961430
Methodology: https://510kreport.com/methodology