Tympendi (810)— 510(k) K260266
Substantially EquivalentGrace Medical, Inc.
FDA 510(k) clearance K260266 for Tympendi (810), Substantially Equivalent on 2026-08-18. Applicant: Grace Medical, Inc.. Device class: 2.
Summary
Grace Medical's Tympendi, model 810, is filed under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)). The record doesn't describe the product further.
Class II, 21 CFR 874.3620. Ear, Nose, Throat is both the classification panel and the review panel. It was a Traditional 510(k).
Grace Medical filed from Memphis, Tennessee. The decision came 202 calendar days after receipt (January 28 to August 18, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Grace Medical, Inc.
- Product code
- Product code KHJ
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
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