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GripTract-GI Endoscopic Tissue Manipulator

FDA UDI

Class II (US FDA UDI)

by Actuated Medical, Inc.

Identity

Trade Name
GripTract-GI Endoscopic Tissue Manipulator FDA UDI
Generic Name
Externally-mounted endoscopic tissue manipulator FDA UDI
Device Name
GripTract-GI Model GT-CM130 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-CM130 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 130 -133 cm. FDA UDI
Model / Reference
GT-CM130 FDA UDI
Description
GripTract-GI Model GT-CM130 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-CM130 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 130 -133 cm. FDA UDI

Identifiers

Primary DI / UDI-DI
00850458007157 FDA UDI
510(k) Number
K242325 FDA UDI
FDA Product Code
FDF FDA UDI
GMDN Term
Externally-mounted endoscopic tissue manipulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Externally-mounted endoscopic tissue manipulator

GripTract-GI Endoscopic Tissue Manipulator by Actuated Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Externally-mounted endoscopic tissue manipulator.

Cleared under the same submission

K242325 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Actuated Medical, Inc.

Sources (1)

  • FDA UDI 1cb6626e-2ba8-4fc0-877c-e8bd7767090d 34 fields · synced May 30, 2026