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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 the device name listed in this FDA 510(k) record. The listed applicant is Tusker Medical. It received FDA 510(k) clearance on 2017-06-28 under 510(k) 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. The listed applicant is Tusker Medical. The 510(k) number is K171239.

When did TULA Tube Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for TULA Tube Delivery System?

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

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

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

Other records listing Tusker Medical 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.

PMA P190016Tympanostomy tube delivery product with drugK252436Tula Tympanostomy Tube Delivery Device

Related Devices (Code: ETD)

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.

K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc.K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))Aventamed DacK232702Solo+ Tympanostomy Tube Device (TTD)Aventamed DacK233658Biowy Tym Tube (TT)Biowy CorporationK232059Tympanostomy TubesGrace Medical, Inc.K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc.

Official Source

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

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