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FDA 510(k)

Solo+ Tympanostomy Tube Device (TTD)

K-Number: K232702 · 2024-05-20

ApplicantAventamed Dac
Decision Date2024-05-20
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Solo+ Tympanostomy Tube Device (TTD) is the device name listed in this FDA 510(k) record. The listed applicant is Aventamed Dac. It received FDA 510(k) clearance on 2024-05-20 under 510(k) number K232702. 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+ Tympanostomy Tube Device (TTD) is a medical device that received FDA 510(k) clearance on 2024-05-20. The listed applicant is Aventamed Dac. The 510(k) number is K232702.

When did Solo+ Tympanostomy Tube Device (TTD) receive FDA 510(k) clearance?

Solo+ Tympanostomy Tube Device (TTD) received FDA 510(k) clearance on 2024-05-20, under 510(k) number K232702.

Who is the listed applicant for Solo+ Tympanostomy Tube Device (TTD)?

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

What is the FDA product code for Solo+ Tympanostomy Tube Device (TTD)?

The FDA product code for Solo+ Tympanostomy Tube Device (TTD) is ETD.

Related Clinical Trials

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.

NCT07029997Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube DeviceRECRUITINGNCT05741333In-Office Clinical Study of the Solo+ TTDACTIVE_NOT_RECRUITING

Other records listing Aventamed Dac 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.

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))

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 DacK233658Biowy Tym Tube (TT)Biowy CorporationK232059Tympanostomy TubesGrace Medical, Inc.K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc.K200952Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc.

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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