Gordian Surgical

FDA Regulatory Profile

Gordian Surgical appears in FDA public data with 1 recall, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0398-2021, Class II) was initiated on September 22, 2020. Its most recent 510(k) clearance was granted on December 16, 2025.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Known Names

g surgical, g surgical co

Recent Recalls

NumberClassProductDate
Z-0398-2021Class IITroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic enSeptember 22, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K253620TroClose 1200December 16, 2025
K171494TroClose1200, TroClose1200 CannulaJune 15, 2017
K160564TroClose1200November 17, 2016