510(k) clearance
Tympendi™ (810)
- 510(k) number
- K260266
- Applicant
- Grace Medical, Inc.
- Decision date
- Aug 18, 2026
- Date received
- Jan 28, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KHJ
- Device type
- Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Device class
- Class II
- Regulation
- 21 CFR 874.3620
- Advisory committee
- Ear, Nose, Throat
- Statement or summary
- Summary
- Third party
- N
- Location
- Memphis, TN, US