TroClose1200, TroClose1200 Cannula— 510(k) K171494

Clearance details

Applicant

Gordian Surgical, Ltd.

Product code

Code GAM

Device class

Class 2

Regulation

21 CFR 878.4493

Advisory panel

General, Plastic Surgery

Date received

2017-05-22

Decision date

2017-06-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Misgav Business Park, IL

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• K253620 — TroClose 12002025-12-16

• K160564 — TroClose12002016-11-17

Death

45

Injury

5,711

Malfunction

30,744

Other

4

Total

36,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0398-2021 — TroClose 1200 - Product Usage: 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. It is comprised of a single patient use, bladeless Obturator designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two synthetic absorbable sutures, each attached to a synthetic absorbable anchor. The deployment of the anchors and sutures is achieved by utilizing a mechanism within the Obturator. The Cannula is 115 mm long and is compatible for use with laparoscopic devices of 5 - 12 mm outer diameter.Class II·Terminated·Gordian Surgical·20200922

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171494.