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The Tracker / September 2026 / K260446

510(k) cleared

Tontarra Punches and Rongeurs

Tontarra Medizintechnik GmbH · Sep 15, 2026 · K260446

FDA cleared the Tontarra Punches and Rongeurs from Tontarra Medizintechnik GmbH on Sep 15, 2026 under K260446, a traditional 510(k). The device falls under product code HAE, Rongeur, Manual, regulated at 21 CFR 882.4840 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 11, 2026. The decision came 216 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Tontarra Medizintechnik GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260446?

K260446 is the FDA 510(k) for Tontarra Punches and Rongeurs, submitted by Tontarra Medizintechnik GmbH. FDA's decision date was Sep 15, 2026, under product code HAE (Rongeur, Manual).

Who makes the Tontarra Punches and Rongeurs?

Tontarra Medizintechnik GmbH, based in Wurmlingen, is the applicant of record for K260446.

How long did the K260446 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on Sep 15, 2026, 216 days later.

← All decisions in September 2026