GripTract-GI Endoscopic Tissue Manipulator

Primary DI
00850458007195
Brand
GripTract-GI Endoscopic Tissue Manipulator
Company
ACTUATED MEDICAL, INC.
Model
GT-GS100
Device description
GripTract-GI Model GT-GS100 is a single-use, non-sterile, endoscope accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment. GripTract Model GT-GS100 is indicated for use in the upper gastrointestinal tract with any standard endoscope with a distal tip outer diameter of 9.8 – 10.5 mm and a working length of 103 -110 cm.
Published
2025-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FDSGastroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251041000GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, Inc.2025-10-31FDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850458007192PackageGS15In Commercial Distribution
00850458007195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085045800719210850458007192
00850458007195008504580071958504580071950850458007195

GMDN Terms#

Term, Definition table
TermDefinition
Externally-mounted endoscopic tissue manipulatorA non-powered manual surgical instrument designed to be externally-mounted onto a gastrointestinal endoscope to assist intraoperative manoeuvring of the distal end of endoscopic instruments (e.g., electrosurgical electrode), and atraumatically retract, grasp and manipulate tissue to optimise site access and visualization during endoscopic surgery; it may also be used to remove foreign bodies. It has integrated distal finger-like effectors, long flexible extraluminal shafts, and proximal rotational and translational knob controls; unlike endoscopic forceps it is not designed with hinged jaws. It is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791379030
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00850458007003TubeClearGJ-1422GJ-14222021-01-01
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