# K032676: Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Oct 30, 2003 after 62 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
No predicates in its family tree.
172 later devices descend from it; 26 cite it directly.
0 of 173 devices 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) ENDOPATH' Dilating Tip Trocar: named in the summary without a submission number
- (no number) ENDOPATH@Non-Bladed Obturator and Sleeve: named in the summary without a submission number
- (no number) ENDOPATH@Bladeless Trocar: named in the summary without a submission number
- (no number) ENDOPATH@Blunt Tip Trocar: named in the summary without a submission number
- (no number) ENDOPATH@OneSeal Reducer Cap: named in the summary without a submission number
- (no number) ENDOPATH' TRISTARTMLow Profile Trocars with Threaded Sleeve: named in the summary without a submission number

## Most influential descendants
- K070158: R-Port Laparoscopic Access Device (2007), 69 descendants of its own
- K073170: R-Port II Laparoscopic Access Device (2007), 68 descendants of its own
- K082619: Sils Port, Models SILSPT5, SILSPT12 (2008), 58 descendants of its own
- K063859: Surgiquest Elastomeric Optical Trocar & Cannula (2007), 54 descendants of its own
- K083211: Airseal Optical Trocar & Cannula System (2008), 51 descendants of its own

## Recalls of this device
- Mar 26, 2018 · Class II · Z-1889-2018: Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle i
- Mar 26, 2018 · Class II · Z-1885-2018: Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle i
- Mar 26, 2018 · Class II · Z-1888-2018: Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle i
- Mar 26, 2018 · Class II · Z-1886-2018: Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle i
- Mar 26, 2018 · Class II · Z-1887-2018: Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle i
- Sep 27, 2010 · Not classified · Z-0336-2011: This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in the ENDOPATH XCEL" with OPTIVIEW" Technology trocar, which potentially can lead to loss of 

## Indications for use
The ENDOPATH@I11 Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments, The trocar may be used with or without visualization for primary and secondary insertions. The ENDOPATH@I11 Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments. The ENDOPATH@I11 Blunt Tip Trocar has applications in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.

Source page: https://510kreport.com/device/K032676
Methodology: https://510kreport.com/methodology