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 Control Box and Clearing Stem

K-Number: K163092 · 2016-11-30

ApplicantActuated Medical, Inc.
Decision Date2016-11-30
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TubeClear Control Box and Clearing Stem is a medical device manufactured by Actuated Medical, Inc.. It received FDA 510(k) clearance on 2016-11-30 under approval number K163092. 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 Control Box and Clearing Stem?

TubeClear Control Box and Clearing Stem is a medical device that received FDA 510(k) clearance on 2016-11-30. It is manufactured by Actuated Medical, Inc.. The 510(k) number is K163092.

When was TubeClear Control Box and Clearing Stem approved by the FDA?

TubeClear Control Box and Clearing Stem received FDA 510(k) clearance on 2016-11-30, under approval number K163092.

What company makes TubeClear Control Box and Clearing Stem?

TubeClear Control Box and Clearing Stem is manufactured by Actuated Medical, Inc..

What is the FDA product code for TubeClear Control Box and Clearing Stem?

The FDA product code for TubeClear Control Box and Clearing Stem is KNT.

Other Devices by Actuated Medical, Inc.

K172556TubeClear System K200646TubeClear 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)

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 K173355Gastric Sizing Balloon CatheterCook Incorporated

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.

↑