K260620
- 510(k) number
- K260620
- Device name
- SeptAlign (SPLN001)
- Applicant
- Spirair, Inc. Ca · US
- Product code
- NHB — Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- Decision date
- 2026-07-30
- Date received
- 2026-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K260620.pdf
Official FDA record: K260620
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.