Cleared Traditional

K211572 - Aesculap Slim Clip Applier

K211572 is an FDA 510(k) clearance for Aesculap Slim Clip Applier, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code HCI cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K211572 · Aesculap, Inc. · Neurology device
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Dec 2021
Decision
206d
Days
Class 2
Risk

K211572 is an FDA 510(k) clearance for the Aesculap Slim Clip Applier. Classified as Applier, Aneurysm Clip (product code HCI), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 13, 2021 after a review of 206 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4175 - 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K211572

510(k) Number K211572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2021
Decision Date December 13, 2021
Days to Decision 206 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
58d slower than avg
Panel avg: 148d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCI Device Classification - Class 2, Special Controls

Product Code HCI Applier, Aneurysm Clip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4175
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 - HCI Applier, Aneurysm Clip

All 13
Devices cleared under the same product code (HCI) and FDA review panel - the closest regulatory comparables to K211572.
Sugita AVM Microclip Applier
K221524 · Mizuho America, Inc. · Jun 2022
Aesculap Slim Clip Applier
K180914 · Aesculap, Inc. · Apr 2018
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