# K171494: TroClose1200, TroClose1200 Cannula

- Pathway: 510(k) (Special)
- Applicant: Gordian Surgical, Ltd.
- Decided: Jun 15, 2017 after 24 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 1 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K253620: TroClose 1200 (2025), 0 descendants of its own

## Recalls of this device
- Sep 22, 2020 · Class II · Z-0398-2021: Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).

## Indications for use
The TroClose1200™ bladeless trocar is intended for use in a variety of gynecologic, general and urologic endoscopic procedures to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic/ laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions

Source page: https://510kreport.com/device/K171494
Methodology: https://510kreport.com/methodology