K250256
- 510(k) number
- K250256
- Device name
- 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))
- Applicant
- Aventamed Dac IE
- Product code
- ETD — Tube, Tympanostomy
- Decision date
- 2025-04-28
- Date received
- 2025-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250256.pdf
Official FDA record: K250256
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.