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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
510(k) Number K260266
Device Name Tympendi™ (810)
Applicant
Grace Medical, Inc.
8500 Wolf Lake Dr.
Suite 110
Memphis,  TN  38133
Applicant Contact Thomas Fearnley
Correspondent
Grace Medical, Inc.
8500 Wolf Lake Dr.
Suite 110
Memphis,  TN  38133
Correspondent Contact Thomas Fearnley
Regulation Number874.3620
Classification Product Code
KHJ  
Subsequent Product Code
MIB  
Date Received01/28/2026
Decision Date 08/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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