K260266
- 510(k) number
- K260266
- Device name
- Tympendi (810)
- Applicant
- Grace Medical, Inc. TN · US
- Product code
- KHJ — Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Mater
- Decision date
- 2026-08-18
- Date received
- 2026-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K260266.pdf
Official FDA record: K260266
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.