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FDA 510(k)

TULA Tube Delivery System

K-Number: K171239 · 2017-06-28

ApplicantTusker Medical
Decision Date2017-06-28
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TULA Tube Delivery System is a medical device manufactured by Tusker Medical. It received FDA 510(k) clearance on 2017-06-28 under approval number K171239. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TULA Tube Delivery System?

TULA Tube Delivery System is a medical device that received FDA 510(k) clearance on 2017-06-28. It is manufactured by Tusker Medical. The 510(k) number is K171239.

When was TULA Tube Delivery System approved by the FDA?

TULA Tube Delivery System received FDA 510(k) clearance on 2017-06-28, under approval number K171239.

What company makes TULA Tube Delivery System?

TULA Tube Delivery System is manufactured by Tusker Medical.

What is the FDA product code for TULA Tube Delivery System?

The FDA product code for TULA Tube Delivery System is ETD.

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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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