# K253620: TroClose 1200

- Pathway: 510(k) (Special)
- Applicant: Gordian Surgical, Ltd.
- Decided: Dec 16, 2025 after 28 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011257 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171494: TroClose1200, TroClose1200 Cannula, Gordian Surgical, Ltd. (2017) Summary page 5.
- K160564: TroClose1200, Gordian Surgical, Ltd. (2016) Summary page 5.

## 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/K253620
Methodology: https://510kreport.com/methodology