FDA 510(k)

Biowy Tym Tube (TT)

K-Number: K233658 · 2024-02-16

Decision Date2024-02-16

Product CodeETD

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Biowy Tym Tube (TT) is a medical device manufactured by Biowy Corporation. It received FDA 510(k) clearance on 2024-02-16 under approval number K233658. 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 Biowy Tym Tube (TT)?

Biowy Tym Tube (TT) is a medical device that received FDA 510(k) clearance on 2024-02-16. It is manufactured by Biowy Corporation. The 510(k) number is K233658.

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

Biowy Tym Tube (TT) received FDA 510(k) clearance on 2024-02-16, under approval number K233658.

What company makes Biowy Tym Tube (TT)?

Biowy Tym Tube (TT) is manufactured by Biowy Corporation.

What is the FDA product code for Biowy Tym Tube (TT)?

The FDA product code for Biowy Tym Tube (TT) is ETD.

Other Devices by Biowy Corporation

K173956Biowy PlCC Catheter K192246Biowy PICC Catheter S Kit

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 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 Dac

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.