# K965045: Tristar LP Torcar with Low Profile Threaded Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: May 5, 1997 after 139 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K993653: Micro-France Trocars and Accessories (2000), 0 descendants of its own

## Indications for use
The TRISTAR™ LP Trocar with Low Profile Threaded Sleeve has application in thoracic, general, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. The instrument is intended for insertion under direct visualization for secondary port locations.

Source page: https://510kreport.com/device/K965045
Methodology: https://510kreport.com/methodology