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TroClose1200™ GSTC1200

by Gordian Surgical, Ltd. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290017191003 UDI-DI Date7 Dec 2017ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0398-2021 FDA Class II initiated 22 Sep 2020

    Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TroClose1200™
Generic Name
Laparoscopic access cannulation/wound closure set
Model / Reference
GSTC1200
Primary DI / UDI-DI
07290017191003
510(k) Number
FDA Product Code
GCJ, GAM
GMDN Term
Laparoscopic access cannulation/wound closure set
Device Class
Class II
Regulation Number
876.1500, 878.4493
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Length — 115 Millimeter
Lumen/Inner Diameter — 12 Millimeter

Related devices

Category: Laparoscopic access cannulation/wound closure set

Cleared under the same submission (K171494)

Other devices from Gordian Surgical, Ltd.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No