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FDA 510(k)

Tula Tympanostomy Tube Delivery Device

K-Number: K252436 · 2026-04-23

ApplicantTusker Medical, Inc.
Decision Date2026-04-23
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Tula Tympanostomy Tube Delivery Device is a medical device manufactured by Tusker Medical, Inc.. It received FDA 510(k) clearance on 2026-04-23 under approval number K252436. 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 Tympanostomy Tube Delivery Device?

Tula Tympanostomy Tube Delivery Device is a medical device that received FDA 510(k) clearance on 2026-04-23. It is manufactured by Tusker Medical, Inc.. The 510(k) number is K252436.

When was Tula Tympanostomy Tube Delivery Device approved by the FDA?

Tula Tympanostomy Tube Delivery Device received FDA 510(k) clearance on 2026-04-23, under approval number K252436.

What company makes Tula Tympanostomy Tube Delivery Device?

Tula Tympanostomy Tube Delivery Device is manufactured by Tusker Medical, Inc..

What is the FDA product code for Tula Tympanostomy Tube Delivery Device?

The FDA product code for Tula Tympanostomy Tube Delivery Device is ETD.

Related Clinical Trials

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Related PubMed Literature

PMID: 41967377 Governing the rise of AI in healthcare: A comparative governance document and implementation implications across five jurisdictions. Social science & medicine (1982) (2026) PMID: 40553217 Device reps in theatre: blurred boundaries or regulatory gaps? Monash bioethics review (2025) PMID: 39855465 [Review of practices concerning the delivery of an international implant card following the implantation of a medical device]. Annales pharmaceutiques francaises (2025)

Other Devices by Tusker Medical, Inc.

PMA P190016Tympanostomy tube delivery product with drug

Related Devices (Code: ETD)

K171239TULA Tube Delivery SystemTusker Medical K200952Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc. K232059Tympanostomy TubesGrace Medical, Inc. K232702Solo+ Tympanostomy Tube Device (TTD)Aventamed Dac K233658Biowy Tym Tube (TT)Biowy Corporation

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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