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

Name: FDA 510(k) clearance K250256
Creator: U.S. Food and Drug Administration
Published: 2025-04-28

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. Device class: 2.

Clearance details

Applicant: Aventamed Dac
Product code: Code ETD
Device class: Class 2
Regulation: 21 CFR 874.3880
Advisory panel: Ear, Nose, Throat
Date received: 2025-01-28
Decision date: 2025-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bishopstown, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code ETD

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K252436 — Tula Tympanostomy Tube Delivery Device2026-04-23
K232702 — Solo+ Tympanostomy Tube Device (TTD)2024-05-20
K233658 — Biowy Tym Tube (TT)2024-02-16
K232059 — Tympanostomy Tubes2023-11-24
K221254 — Hummingbird Tympanostomy Tube System2022-07-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.