Cleared Traditional

K150468 - Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150468 · K2 Medical GmbH & Co. KG · Neurology device
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Feb 2016
Decision
371d
Days
Class 2
Risk

K150468 is an FDA 510(k) clearance for the Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by K2 Medical GmbH & Co. KG (Tuttlingen, DE). The FDA issued a Cleared decision on February 29, 2016 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K2 Medical GmbH & Co. KG devices

Submission Details

510(k) Number K150468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2015
Decision Date February 29, 2016
Days to Decision 371 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 148d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 35
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