Cleared Traditional

K180757 - D-Clip (FDA 510(k) Clearance)

Also includes:
D-Clip Applier

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

K180757 · Peter Lazic GmbH · Neurology device
Apr 2019
Decision
386d
Days
Class 2
Risk

K180757 is an FDA 510(k) clearance for the D-Clip. Classified as Clip, Aneurysm (product code HCH), Class II - Special Controls.

Submitted by Peter Lazic GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on April 12, 2019 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5200 - 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.

Submission Details

510(k) Number K180757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2018
Decision Date April 12, 2019
Days to Decision 386 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 163d · This submission: 386d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCH Clip, Aneurysm
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5200
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.