# K982417: Innerdyne Step Trocar Expandable Port, Step

- Pathway: 510(k) (Traditional)
- Applicant: Innerdyne, Inc.
- Decided: Oct 7, 1998 after 86 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) InnerDyne, Inc., Step® device versions: named in the summary without a submission number
- (no number) InnerDyne, Inc., R.E.D.® device versions: named in the summary without a submission number

## Indications for use
The InnerDyne, Inc., Step® device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures. Laparoscopic access to the abdominal region, both primary and secondary punctures; Thoracoscopic access to the thoracic cavity, both primary and secondary punctures; and Percutaneous access into hollow body organs with typical use in such procedures as percutaneous gastrostomy, percutaneous enterostomy, percutaneous cystostomy, percutaneous cholecystostomy, and dilation of biliary and urethral strictures.

Source page: https://510kreport.com/device/K982417
Methodology: https://510kreport.com/methodology