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))— 510(k) K250256

Substantially Equivalent

Aventamed Dac

FDA 510(k) clearance K250256 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)), Substantially Equivalent on 2025-04-28. Applicant: Aventamed Dac.

Clearance details

Applicant: Aventamed Dac
Product code: Code ETD
Advisory panel: Ear, Nose, Throat
Date received: 2025-01-28
Decision date: 2025-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bishopstown, IE

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