FDA.reportPublic FDA data

SutureTOOL

Primary DI
07350154050004
Brand
SutureTOOL
Company
Suturion AB
Model
BOM 1018S rev 10 SutureTOOL
Published
2025-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GABNeedle, Suturing, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242835000Suture-TOOL SystemSuturion AB2025-01-22NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350154050004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350154050004073501540500047350154050004

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
353236163
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17350154050513Suture USP 2-0BOM 1020S rev 05 Needle & Suture Sterilized2025-12-15
17350154050551Suture USP 0BOM 1055S rev 05 Suture PDO USP 0 - Sterilized2025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918121994AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-04-06
16931918157016AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-01-21
16931918179858AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-21
16931918144948AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-20
10192253052329DevonCardinal Health 200, LLCGAB2025-05-29
10192253052138DevonCardinal Health 200, LLCGAB2025-03-27
10192253052145DevonCardinal Health 200, LLCGAB2025-03-27
10192253052152DevonCardinal Health 200, LLCGAB2025-03-27
10192253052169DevonCardinal Health 200, LLCGAB2025-03-27
10192253052176DevonCardinal Health 200, LLCGAB2025-03-27
10192253052183DevonCardinal Health 200, LLCGAB2025-03-27
10192253052190DevonCardinal Health 200, LLCGAB2025-03-27
10192253052206DevonCardinal Health 200, LLCGAB2025-03-27
10192253052213DevonCardinal Health 200, LLCGAB2025-03-27
10192253052220DevonCardinal Health 200, LLCGAB2025-03-27
10192253052237DevonCardinal Health 200, LLCGAB2025-03-27
10192253052244DevonCardinal Health 200, LLCGAB2025-03-27
10192253052251DevonCardinal Health 200, LLCGAB2025-03-27
10192253052268DevonCardinal Health 200, LLCGAB2025-03-27
10192253052275DevonCardinal Health 200, LLCGAB2025-03-27
10192253052282DevonCardinal Health 200, LLCGAB2025-03-27
10192253052299DevonCardinal Health 200, LLCGAB2025-03-27
10192253052312DevonCardinal Health 200, LLCGAB2025-03-27
10192253052336DevonCardinal Health 200, LLCGAB2025-03-27
10192253052343DevonCardinal Health 200, LLCGAB2025-03-27
10192253052350DevonCardinal Health 200, LLCGAB2025-03-27
10192253052367DevonCardinal Health 200, LLCGAB2025-03-27
10192253052374DevonCardinal Health 200, LLCGAB2025-03-27
10192253052381DevonCardinal Health 200, LLCGAB2025-03-27
10192253053357DevonCardinal Health 200, LLCGAB2025-03-27