ACTUATED MEDICAL, INC.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• GripTract-GI? Endoscopic Tissue Manipulator Upper GI Model GT-GS100

  2025-10-31

  Actuated Medical, Inc.

• GripTract-GI Endoscopic Tissue Manipulator Lower GI Models

  2024-10-04

  Actuated Medical, Inc.

• GripTract-GI Endoscopic Tissue Manipulator

  2023-11-03

  Actuated Medical, Inc.

• IO Needle Safety Sheath

  2022-10-31

  Actuated Medical, Inc.

• TubeClear System

  2020-12-04

  Actuated Medical, Inc.

• TubeClear System

  2018-06-29

  Actuated Medical, Inc.

• TubeClear Control Box And Clearing Stem

  2016-11-30

  Actuated Medical, Inc.

• TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)

  2013-08-16

  ACTUATED MEDICAL, INC.

• TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)

  2012-12-20

  ACTUATED MEDICAL, INC.

• TUBECLEAR

  2012-06-13

  ACTUATED MEDICAL, INC

GUDID#

• TubeClear - G-1008

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-03-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-03-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Control Box Model 101

  ACTUATED MEDICAL, INC.

  2016-09-08

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• 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 Model 101 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 101 is indicated for use in the large intestine with any standard endoscope that has 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

• TubeClear - TubeClear Clearing Stem for clearing clogs / occlusions in silicone AMT, MIC, and MIC-KEY gastro-jejunostomy tubes size 14-22 Fr.

  ACTUATED MEDICAL, INC.

  2021-01-01

• 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

• ShippertTech - The IO Needle Safety Sheath (IOSS) is a single-use, non-sterile, anti-needlestick accessory to assist in the removal of intraosseous (IO) needles. IOSS is indicated for use with 25mm and 45mm EZ-IO® Vascular Access Needles and BD Luer-Lok™ 10 mL Syringe.

  ACTUATED MEDICAL, INC.

  2023-07-26

• TubeClear - G-1008

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-10-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2016-10-27

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-03-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-03-02

• TubeClear - Clearing Stem

  ACTUATED MEDICAL, INC.

  2017-10-02