Cleared Traditional

D-Clip; D-Clip Applier

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

About This 510(k) Submission

K180757 is an FDA 510(k) clearance for the D-Clip; D-Clip Applier, a Clip, Aneurysm (Class II — Special Controls, product code HCH), submitted by Peter Lazic GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on April 12, 2019, 386 days after receiving the submission on March 22, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5200.

Submission Details

510(k) Number K180757 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HCH — Clip, Aneurysm
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5200

Similar Devices — HCH Clip, Aneurysm

All 35
Sugita AVM Microclips
K211183 · Mizuho America, Inc. · Mar 2022
YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS
K131500 · Aesculap, Inc. · Jan 2014
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
K091921 · Codman & Shurtleff, Inc. · Sep 2009
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
K081640 · Gimmi GmbH · May 2009
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS
K081489 · Peter Lazic GmbH · Sep 2008
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
K060915 · Kirwan Surgical Products, Inc. · Apr 2007