# K012539: Verastep

- Pathway: 510(k) (Special)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Sep 6, 2001 after 30 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: 2 generations back to K940232 (1994). 6 ancestors in all.
67 later devices descend from it; 5 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961940: Innerdyne Step Trocar Expandable Port, Onestep, Innerdyne, Inc. (1996) Summary page 1.
- K954108: Modified Versaport, United States Surgical, A Division of Tyco Healthc (1995) Summary page 1.

## Most influential descendants
- K072814: Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic Procedures (2008), 59 descendants of its own
- K082619: Sils Port, Models SILSPT5, SILSPT12 (2008), 58 descendants of its own
- K090902: Spider Single Port Surgical Device, Support Arm Accessory,  Model 90001, 90002, 90003 (2009), 46 descendants of its own
- K112208: Intutive Surgical DA Vinci Single Site Instruments and Accessories (2011), 43 descendants of its own
- K120215: Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus Grasper, Single-Site Crocodile (2012), 42 descendants of its own

## Indications for use
The VersaStep* single use system is intended to provide dilation access to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures. The VersaStep* single use system is indicated for the following uses: * Laparoscopic access to the abdominal cavity, both primary and secondary punctures = Thoracoscopic access to the thoracic cavity, both primary and secondary punctures

Source page: https://510kreport.com/device/K012539
Methodology: https://510kreport.com/methodology