Cleared Traditional

K260446 - Tontarra Punches and Rongeurs

K260446 is an FDA 510(k) clearance for Tontarra Punches and Rongeurs, manufactured by Tontarra Medizintechnik GmbH. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K260446 · Tontarra Medizintechnik GmbH · Neurology device
Download Printable Device Report (PDF)
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Sep 2026
Decision
216d
Days
Class 2
Risk

K260446 is an FDA 510(k) clearance for the Tontarra Punches and Rongeurs. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Tontarra Medizintechnik GmbH (Wurmlingen, DE). The FDA issued a Cleared decision on September 15, 2026 after a review of 216 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tontarra Medizintechnik GmbH devices

FDA 510(k) Submission Details - K260446

510(k) Number K260446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2026
Decision Date September 15, 2026
Days to Decision 216 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 149d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAE Device Classification - Class 2, Special Controls

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HAE Rongeur, Manual

All 28
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