FDA.reportPublic FDA data

ACTUATED MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30096981863009698186ACTUATED MEDICAL, INC.1N2026-01-01320 Rolling Ridge Dr Bellefonte PA US 16823

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1426821801077870K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100FDS2025-10-31
1426821378175512K242325GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF2024-10-04
1426821489392068K200646TubeClear SystemKNT2020-12-04
1426821478964154K172556TubeClear SystemKNT2018-06-29
1426821039065962K163092TubeClear Control Box and Clearing StemKNT2016-11-30
1426821828848055K131052TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)KNT2013-08-16
1426821063331610K123659TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)KNT2012-12-20
1426821037538499K121571TUBECLEARKNT2012-06-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNT62020-12-04
FDS12025-10-31
FDF12024-10-04

PMN#

GUDID#

GripTract-GI Endoscopic Tissue Manipulator - 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.

ACTUATED MEDICAL, INC.

2025-12-23

GripTract-GI Endoscopic Tissue Manipulator - 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.

ACTUATED MEDICAL, INC.

2025-01-16

GripTract-GI Endoscopic Tissue Manipulator - 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.

ACTUATED MEDICAL, INC.

2025-01-16

GripTract-GI Endoscopic Tissue Manipulator - GripTract-GI Model GT-CL130 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-CL130 is indicated for use in the large intestine with any standard endoscope with a distal tip outer diameter of 12.8 – 13.3 mm and a working length of 130 -133 cm.

ACTUATED MEDICAL, INC.

2025-01-16

GripTract-GI Endoscopic Tissue Manipulator - GripTract-GI Model GT-CL170 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-CL170 is indicated for use in the large intestine with any standard endoscope with a distal tip outer diameter of 12.8 – 13.3 mm and a working length of 168 -170 cm.

ACTUATED MEDICAL, INC.

2025-01-16