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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 the device name listed in this FDA 510(k) record. The listed applicant is Actuated Medical, Inc.. It received FDA 510(k) clearance on 2020-12-04 under 510(k) 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. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K200646.

When did TubeClear System receive FDA 510(k) clearance?

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

Who is the listed applicant for TubeClear System?

The FDA 510(k) record lists Actuated Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TubeClear System?

The FDA product code for TubeClear System is KNT.

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Other records listing Actuated Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100K242325GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsK231254GripTract-GI Endoscopic Tissue ManipulatorK220890IO Needle Safety SheathK172556TubeClear SystemK163092TubeClear Control Box and Clearing Stem

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Related Devices (Code: KNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, 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.

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