ACTUATED MEDICAL, INC.

FDA Device Registration & Listing · Bellefonte, PA, US · Registration 3009698186

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009698186
FEI Number
3009698186
Entity Name
ACTUATED MEDICAL, INC.
City/State/Country
Bellefonte, PA, US
Establishment Address
320 Rolling Ridge Dr, Bellefonte, PA 16823, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Actuated Medical, Inc. (Owner Number: 10041111)
Owner / Operator Contact Address
320 Rolling Ridge Drive, Bellefonte, PA 16823, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K131052
PMA Number
N/A

All Registered Proprietary Names

GripTract-GI Endoscopic Tissue Manipulator TubeClear TubeClear Clearing Stem Models TC-1018, TC-0812, TC-0608 GripTract-GI Endoscopic Tissue Manipulator TubeClear

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-12-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2020-12-14
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2017-01-12
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-12-17
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2013-12-05
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2013-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Actuated Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26
K955248 United States Endoscopy Group, Inc. U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT 1996-05-21
K872921 Medical Support, Inc. MSS ENTERAL DELIVERY SET 1987-12-03
K180622 Covidien Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port 2018-10-23

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3015136743 STERI-TECH CO.,LTD. KAZO-SHI Saitama, JP
3042225166 FUJIFILM Corporation Medical Systems Research & Development Center Kaisei Ashigarakami-Gun Kanagawa, JP
3008797804 ALTON SHANGHAI MEDICAL INSTRUMENTS CO LTD Shanghai, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009698186. Last updated year: 2026. Please use registration number 3009698186 when referencing this establishment in official correspondence.
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