# K971475: Shielded Surgical Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Aug 21, 1997 after 120 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
No predicates in its family tree.
26 later devices descend from it; 4 cite it directly.
0 of 27 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 no predicate by number.

## Most influential descendants
- K112358: Unimax Trocar System (2011), 16 descendants of its own
- K133845: 8MM Trocar Kit (2014), 6 descendants of its own
- K141594: Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar (2015), 5 descendants of its own
- K181395: Universal Cannula Seal (5-12 mm) (2018), 4 descendants of its own
- K231358: Universal Seal (5-12 mm) (2023), 3 descendants of its own

## Indications for use
The ENDOPATH® Dilating Tip Trocar has application in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments.

Source page: https://510kreport.com/device/K971475
Methodology: https://510kreport.com/methodology