# K112349: Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar

- Pathway: 510(k) (Special)
- Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
- Decided: Sep 1, 2011 after 16 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011257 (2001). 2 ancestors in all.
15 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100548: Versaport Bladeless Low Profile Trocar Model NB3SHFLP, NB5SHFLP, NB5STFLP, Covidien Lp, Formerly Registered AS Tyco Healthcar (2010) Summary page 1.
- K011257: Endopath Non-Bladed Obturator Trocar System (5 MM), Ethicon Endo-Surgery, Inc. (2001) Summary page 2.

## Most influential descendants
- K130435: Versaport V2 Bladeless Optical Trocar (2013), 11 descendants of its own
- K151548: VersaOne Bladed Trocar, VersaOne Bladeless Trocar (2015), 7 descendants of its own
- K163654: VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar (2017), 1 descendant of its own
- K160564: TroClose1200 (2016), 1 descendant of its own
- K162584: VersaOne Bladeless Trocar (2016), 1 descendant of its own

## Recalls of this device
- May 6, 2013 · Class II · Z-1469-2013: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
- May 6, 2013 · Class II · Z-1467-2013: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
- May 6, 2013 · Class II · Z-1472-2013: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
- May 6, 2013 · Class II · Z-1471-2013: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
- May 6, 2013 · Class II · Z-1470-2013: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
- May 6, 2013 · Class II · Z-1468-2013: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

## Indications for use
The Versaport Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

Source page: https://510kreport.com/device/K112349
Methodology: https://510kreport.com/methodology