Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TubeClear System

K-Number: K200646 · 2020-12-04

ApplicantActuated Medical, Inc.
Decision Date2020-12-04
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TubeClear System is a medical device manufactured by Actuated Medical, Inc.. It received FDA 510(k) clearance on 2020-12-04 under approval number K200646. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TubeClear System?

TubeClear System is a medical device that received FDA 510(k) clearance on 2020-12-04. It is manufactured by Actuated Medical, Inc.. The 510(k) number is K200646.

When was TubeClear System approved by the FDA?

TubeClear System received FDA 510(k) clearance on 2020-12-04, under approval number K200646.

What company makes TubeClear System?

TubeClear System is manufactured by Actuated Medical, Inc..

What is the FDA product code for TubeClear System?

The FDA product code for TubeClear System is KNT.

Related Clinical Trials

NCT07570537 TubeClear System Evaluation in Pediatric Patients NOT_YET_RECRUITING

Other Devices by Actuated Medical, Inc.

K163092TubeClear Control Box and Clearing Stem K172556TubeClear System K220890IO Needle Safety Sheath K231254GripTract-GI Endoscopic Tissue Manipulator K242325GripTract-GI Endoscopic Tissue Manipulator Lower GI Models K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100

View all 7 devices →

Related Devices (Code: KNT)

K163092TubeClear Control Box and Clearing StemActuated Medical, Inc. K162110CORGRIP NG/NI Tube Retention SystemCorpak Medsystems, Inc. A Division of Haylard Health K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletSyncro Medical Innovations, Inc. K152246Aquarius Stoma Measuring DeviceDegania Silicone , Ltd. K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management KitConsure Medical Pvt , Ltd. K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑