Cleared Traditional

Aesculap Slim Clip Applier

K180914 · Aesculap, Inc. · Neurology
Apr 2018
Decision
8d
Days
Class 2
Risk

About This 510(k) Submission

K180914 is an FDA 510(k) clearance for the Aesculap Slim Clip Applier, a Applier, Aneurysm Clip (Class II — Special Controls, product code HCI), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on April 17, 2018, 8 days after receiving the submission on April 9, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4175.

Submission Details

510(k) Number K180914 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2018
Decision Date April 17, 2018
Days to Decision 8 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCI — Applier, Aneurysm Clip
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4175

Similar Devices — HCI Applier, Aneurysm Clip

All 13
Sugita AVM Microclip Applier
K221524 · Mizuho America, Inc. · Jun 2022
Aesculap Slim Clip Applier
K211572 · Aesculap, Inc. · Dec 2021
Aesculap Slim Clip Applier Forceps
K173271 · Aesculap, Inc. · Nov 2017
MEDICON YASARGIL CLIP APPLYING FORCEPS
K010910 · Medicon EG · Aug 2001
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
K994191 · Nmt Medical, Inc. · Feb 2000
AESCULAP AXIAL CLIP APPLIER
K984109 · Aesculap, Inc. · Feb 1999