# K043253: Vanguard Reprocessed Dilating Tip and Blunt Trocars

- Pathway: 510(k) (Traditional)
- Applicant: Vanguard Medical Concepts, Inc.
- Decided: Apr 8, 2005 after 135 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: 1 generation back to K963760 (1997). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020428: Endopath Dilating Tip Trocar, Model #512XD, Ethicon Endo-Surgery, Inc. (2002) Summary page 1.
- K011538: Endopath Non-Bladed Solid Obturator Trocar System, Ethicon Endo-Surgery, Inc. (2001)
- K011257: Endopath Non-Bladed Obturator Trocar System (5 MM), Ethicon Endo-Surgery, Inc. (2001)
- K990028: Endopath Optiview Optical Surgical Obturator and Sleeve, Ethicon Endo-Surgery, Inc. (1999) Summary page 1.
- K971475: Shielded Surgical Trocar, Ethicon Endo-Surgery, Inc. (1997) Summary page 1.
- K963760: Non-Shielded Surgical Trocar and Sleeve, Ethicon Endo-Surgery, Inc. (1997) Summary page 1.

## 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
- Mar 17, 2006 · Not classified · Z-1212-06: Review of complaints and testing show that the distal tip of the trocars may separate while in use.

## 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/K043253
Methodology: https://510kreport.com/methodology