Gordian Surgical

FDA Regulatory Profile

Summary

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

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