FDA.reportPublic FDA data

TroClose1200™

Primary DI
17290017191024
Brand
TroClose1200™
Company
GORDIAN SURGICAL LTD
Model
GSTC1200
Catalog number
GSTC1200
Device description
Gordian TroClose1200™ Integrated Port Closure System
Published
2026-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253620000TroClose 1200Gordian Surgical, Ltd.2025-12-16GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017191024PackageGS16In Commercial Distribution
27290017191021PackageGS12In Commercial Distribution
07290017191027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001719102417290017191024
2729001719102127290017191021
07290017191027072900171910277290017191027

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannulation/wound closure setA collection of sterile devices which includes a laparoscopic access cannula with a dedicated, implantable, bioabsorbable wound closure thread, intended to: 1) puncture the abdominal wall to create an access port for laparoscopic instruments during laparoscopy; and 2) approximate subcutaneous tissue after removal of the cannula. The access cannula is often provided with a shut-off valve, sealing devices, and may include a trocar blade. The thread is integrated within the cannula and consists of a suture with an attached tag (anchor); the tag is designed to be deployed deep to the wound and the suture ligated upon removal of the cannula. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length115Millimeter
Lumen/Inner Diameter12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8447151080info@gordiansurgical.com

Regulatory Flags#

DUNS number
600087854
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017191027TroClose1200™GSTC1200GSTC12002026-02-01
07290017191003TroClose1200™GSTC12002017-12-07
07290017191010TroClose1200™GSTC1200C2017-12-07
17290017191000TroClose1200™GSTC12002017-12-07
27290017191014TroClose1200™GSTC1200C2017-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18