FDA.reportPublic FDA data

TroClose1200™

Primary DI
07290017191027
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2
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

Contacts#

Phone, Email table
PhoneEmail
8447151080info@gordiansurgical.com

Regulatory Flags#

DUNS number
600087854
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290017191024TroClose1200™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
00848657078481AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00848657078498AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GCJ2026-10-08
00190776433697MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433703MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433710MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433727MillenniumAvalign Technologies, Inc.GCJ2026-10-07
00190776433338MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433345MillenniumAvalign Technologies, Inc.GCJ2026-10-05
00190776433031MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776433079MillenniumAvalign Technologies, Inc.GCJ2026-10-01
00190776432911MillenniumAvalign Technologies, Inc.GCJ2026-09-30
00190776432928MillenniumAvalign Technologies, Inc.GCJ2026-09-30
B382SD13768330Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD9156321100Surgical DirectSurgical Direct, Inc.GCJ2026-09-30
B382SD49195170Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
B382SD9039841050Surgical DirectSurgical Direct, Inc.GCJ2026-09-29
00724995268312Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268329Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268336Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268343Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268350Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268374Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268381Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268398Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268404Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268411Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268428Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268435Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268442Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25
00724995268459Snowden-PencerSTERIS Deutschland GmbHGCJ2026-09-25