510(k) K250256 ยท ETD Tube, Tympanostomy
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, Bishopstown, IE |
| Decision | Substantially Equivalent, Apr 28, 2025 |
| Received | Jan 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250256
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.