Tympendi (810)
FDA 510(k) K260266 · Grace Medical, Inc.
510(k) numberK260266
Submission
- Device name
- Tympendi (810)
- Applicant
- Grace Medical, Inc.
Memphis, TN, US - Received
- January 28, 2026
- Decision date
- August 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHJ – Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code KHJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…KHJ · Traditional | Cook Biotech Incorporated | 05/24/2024SE |
| K161000 | Biodesign Otologic Repair GraftKHJ · Special | Cook Biotech Incorporated | 05/11/2016SE |
| K150594 | Biodesign Otologic Repair GraftKHJ · Traditional | Cook Biotech Incorprated | 09/16/2015SE |
| K132198 | Adaptain, Adaptain Fastwrap, Envelock, BiowaiKHJ · Traditional | Ceremed , Inc. | 09/12/2013SE |
| K121360 | Biodesign ENT Repair GraftKHJ · Traditional | Cook Biotech Incorprated | 02/27/2013SE |
| K122561 | Adaptain Fastwrap, Envelock, GraftainKHJ · Traditional | Ceremed , Inc. | 11/27/2012SE |
| K120220 | Adaptain Soluble Implant MaterialKHJ · Traditional | Ceremed , Inc. | 06/06/2012SE |
| K103047 | Ceretene Soluble Implant MaterialKHJ · Traditional | Ceremed , Inc. | 01/05/2011SE |
| K080022 | Gel-Sponge ENT, Absorbable Gelatin Sponge, UspKHJ · Traditional | Vascular Solutions, Inc. | 12/09/2008SE |
| K082245 | Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LvKHJ · Traditional | Ceremed , Inc. | 09/18/2008SE |
More from Ceremed , Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232059 | Tympanostomy TubesETD · Traditional | 11/24/2023SE |
| K161376 | DragonFly Surgical Drill SystemERL · Traditional | 08/25/2016SE |
| K091187 | Grace Dynamic TorpETA · Traditional | 09/14/2009SE |
| K080070 | K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesETB · Traditional | 04/17/2008SE |
| K063374 | Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…ETB · Traditional | 12/06/2006SE |
| K062672 | Grace Medical PC Coated Tympanostomy TubesETD · Traditional | 10/24/2006SE |
| K062385 | Blue PTFE (Fluoroplastic) Ventilation TubesETD · Traditional | 09/27/2006SE |
| K061853 | Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement ProsthesesETB · Traditional | 08/18/2006SE |
| K060518 | Partial Ossicular Replacement ProsthesesETB · Traditional | 06/28/2006SE |
| K991394 | Stapes ProsthesesETB · Special | 05/18/1999SE |
Questions and answers
When was Tympendi (810) cleared by the FDA?
Tympendi (810) (K260266) received a 510(k) decision of Substantially Equivalent on August 18, 2026, 202 days after the submission was received.
What is the product code of K260266?
The FDA product code is KHJ – Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material), a Class II (moderate risk) device regulated under 21 CFR 874.3620.