FDA 510(k)

Tympendi™ (810)

K-Number: K260266 · 2026-08-18

Decision Date2026-08-18

Product CodeKHJ

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Tympendi™ (810) is the device name listed in this FDA 510(k) record. The listed applicant is Grace Medical, Inc.. It received FDA 510(k) clearance on 2026-08-18 under 510(k) number K260266. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tympendi™ (810)?

Tympendi™ (810) is a medical device that received FDA 510(k) clearance on 2026-08-18. The listed applicant is Grace Medical, Inc.. The 510(k) number is K260266.

When did Tympendi™ (810) receive FDA 510(k) clearance?

Tympendi™ (810) received FDA 510(k) clearance on 2026-08-18, under 510(k) number K260266.

Who is the listed applicant for Tympendi™ (810)?

The FDA 510(k) record lists Grace Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tympendi™ (810)?

The FDA product code for Tympendi™ (810) is KHJ.

Other records listing Grace Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KHJ)

K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech Incorporated K161000Biodesign Otologic Repair GraftCook Biotech Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.