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FDA 510(k)

TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)

K-Number: K131052 · 2013-08-16

ApplicantActuated Medical, Inc.
Decision Date2013-08-16
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) 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 2013-08-16 under 510(k) number K131052. 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 MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)?

TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) is a medical device that received FDA 510(k) clearance on 2013-08-16. The listed applicant is Actuated Medical, Inc.. The 510(k) number is K131052.

When did TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) receive FDA 510(k) clearance?

TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) received FDA 510(k) clearance on 2013-08-16, under 510(k) number K131052.

Who is the listed applicant for TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)?

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 MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)?

The FDA product code for TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) is KNT.

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Related Devices (Code: KNT)

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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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