Gordian Surgical

M.P. Misgav Northern, IL

GORDIAN SURGICAL appears in FDA device records in M.P. Misgav Northern, IL. FDA records list 3 510(k) clearances between 2016-11-17 and 2025-12-16, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Gordian Surgical between 2016 and 2025. The busiest year on record is 2016, with 1. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for Gordian Surgical, by decision year
Year	Clearances
2016	1
2017	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K253620	TroClose 1200	GAM	Substantially Equivalent	2025-12-16
K171494	TroClose1200, TroClose1200 Cannula	GAM	Substantially Equivalent	2017-06-15
K160564	TroClose1200	GAM	Substantially Equivalent	2016-11-17

Registered establishments

FDA registered establishments for Gordian Surgical, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3011803381	3011803381	GORDIAN SURGICAL	17 Tchelet Street, M.P. Misgav Northern 2017400 IL	2026	GAM GCJ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
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.	Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).	Class II	2020-09-22	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain