FDA.reportPublic FDA data

GripTract-GI Endoscopic Tissue Manipulator

Primary DI
00850458007164
Brand
GripTract-GI Endoscopic Tissue Manipulator
Company
ACTUATED MEDICAL, INC.
Model
GT-CM170
Device description
GripTract-GI Model GT-CM170 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-CM170 is indicated for use in the large intestine with any standard endoscope with a distal tip outer diameter of 11.5 – 12.0 mm and a working length of 168 -170 cm.
Published
2025-01-16
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
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242325000GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsActuated Medical, Inc.2024-10-04FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850458007161PackageGS15In Commercial Distribution
00850458007164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085045800716110850458007161
00850458007164008504580071648504580071640850458007164

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.

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
00850458007089TubeClearG-10082017-10-02
00850458007096TubeClearG-10092017-10-02
00850458007102TubeClearG-10102017-10-02
00850458007119TubeClearG-10112017-10-02
00850458007126TubeClearG-10122016-10-27
00850458007140TubeClearG-10142016-10-27
00850458007423TubeClear NE-10422016-10-27
00850458007430TubeClearNE-10432016-10-27
00850458007454TubeClearNE-10452017-10-02
00850458007485TubeClearNE-10482016-10-27
00850458007508TubeClearNE-10502016-10-27
00850458007553TubeClearNE-10552016-10-27
00850458007607TubeClearTC-06082017-03-02
00850458007614TubeClearTC-08122017-03-02
00850458007621TubeClearTC-10182017-10-02
00850458007010TubeClearControl Box Model 101101-US2016-09-08
00850458007362TubeClearNE-10362016-10-27
00850458007195GripTract-GI Endoscopic Tissue ManipulatorGT-GS1002025-12-23
00850458007041GripTract-GI Endoscopic Tissue ManipulatorGT-1012025-01-16
00850458007003TubeClearGJ-1422GJ-14222021-01-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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