Biowy Tym Tube (TT)

FDA 510(k) K233658 · Biowy Corporation

Substantially Equivalent

510(k) numberK233658

Submission

Device name
Biowy Tym Tube (TT)
Applicant
Biowy Corporation
Lake Forest, CA, US
Received
November 15, 2023
Decision date
February 16, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ETD – Tube, Tympanostomy
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3880
Specialty
Ear, Nose, Throat
Implant
Yes

Other 510(k)s with product code ETD

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K252436Tula Tympanostomy Tube Delivery DeviceETD · Traditional Tusker Medical, Inc.04/23/2026SE
K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube…ETD · Traditional Aventamed Dac04/28/2025SE
K232702Solo+ Tympanostomy Tube Device (TTD)ETD · Traditional Aventamed Dac05/20/2024SE
K232059Tympanostomy TubesETD · Traditional Grace Medical, Inc.11/24/2023SE
K221254Hummingbird Tympanostomy Tube SystemETD · Traditional Preceptis Medical, Inc.07/27/2022SE
K200952Hummingbird Tympanostomy Tube SystemETD · Traditional Preceptis Medical, Inc.06/05/2020SE
K171239TULA Tube Delivery SystemETD · Special Tusker Medical06/28/2017SE
K151830Hummingbird Tympanostomy TubeETD · Traditional Preceptis Medical09/21/2015SE
K151067Ventilation (Tympanostomy) TubesETD · Traditional Medtronic Xomed, Inc.07/22/2015SE
K142282Hummingbird(Tm) Tympanostomy Tube System (TTS)ETD · Traditional Preceptis Medical04/23/2015SE

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Questions and answers

When was Biowy Tym Tube (TT) cleared by the FDA?

Biowy Tym Tube (TT) (K233658) received a 510(k) decision of Substantially Equivalent on February 16, 2024, 93 days after the submission was received.

What is the product code of K233658?

The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.