# K043594: Vanguard Reprocessed Bladed Trocar, Non-Bladed Trocar, Trocar Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Mar 31, 2005 after 92 days
- Product code: NLM (Laparoscope, General & Plastic Surgery, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940232 (1994). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012539: Verastep, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.
- K963115: Trocar Cannula, United States Surgical, A Division of Tyco Healthc (1997) Summary page 1.
- K954108: Modified Versaport, United States Surgical, A Division of Tyco Healthc (1995) Summary page 1.
- K945457: Trocar ( Accesory), United States Surgical, A Division of Tyco Healthc (1994) Summary page 1.
- K931337: Auto Suture Dilating Cannula, United States Surgical, A Division of Tyco Healthc (1993) Summary page 1.
- (no number) US Surgical (AutoSuture) VersaPort V2 (5-12mm) Trocar System: named in the summary without a submission number
- (no number) US Surgical (AutoSuture) VersaPort RPF (5-12mm) Trocar System: named in the summary without a submission number
- (no number) US Surgical (AutoSuture) VersaPort RT (5-12mm) Trocar System: named in the summary without a submission number
- (no number) US Surgical (AutoSuture) BluntPort (5-12mm) Trocar System: named in the summary without a submission number
- (no number) US Surgical (AutoSuture) VersaStep (5-12mm) Trocar System: named in the summary without a submission number
- (no number) US Surgical (AutoSuture) SpringGrip Anchoring Accessory: named in the summary without a submission number

## Most influential descendants
- K062497: Reprocessed Trocars (2007), 2 descendants of its own
- K132629: Reprocessed Dilating Tip Trocars (2013), 0 descendants of its own
- K100080: Reprocessed Trocars, Model B5LT and CB5LT (2010), 0 descendants of its own

## Recalls of this device
- Oct 19, 2006 · Not classified · Z-0414-2007: The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.

## Indications for use
Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.

Source page: https://510kreport.com/device/K043594
Methodology: https://510kreport.com/methodology