TubeClear System

Tubes, Gastrointestinal (and Accessories)

Actuated Medical, Inc.

The following data is part of a premarket notification filed by Actuated Medical, Inc. with the FDA for Tubeclear System.

Pre-market Notification Details

Device IDK200646
510k NumberK200646
Device Name:TubeClear System
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant Actuated Medical, Inc. 310 Rolling Ridge Dr. Bellefonte,  PA  16823
ContactMichael T. Britton
CorrespondentDouglas R. Dillon
Actuated Medical, Inc. 310 Rolling Ridge Dr. Bellefonte,  PA  16823
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-12
Decision Date2020-12-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850458007003 K200646 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.