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FDA 510(k)

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

K-Number: K250256 · 2025-04-28

ApplicantAventamed Dac
Decision Date2025-04-28
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) is a medical device manufactured by Aventamed Dac. It received FDA 510(k) clearance on 2025-04-28 under approval number K250256. 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 Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))?

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) is a medical device that received FDA 510(k) clearance on 2025-04-28. It is manufactured by Aventamed Dac. The 510(k) number is K250256.

When was Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) approved by the FDA?

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) received FDA 510(k) clearance on 2025-04-28, under approval number K250256.

What company makes Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))?

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) is manufactured by Aventamed Dac.

What is the FDA product code for Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))?

The FDA product code for Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) is ETD.

Related Clinical Trials

NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT05741333 In-Office Clinical Study of the Solo+ TTD ACTIVE_NOT_RECRUITING NCT03836482 Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD RECRUITING

Other Devices by Aventamed Dac

K232702Solo+ Tympanostomy Tube Device (TTD)

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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