Aesculap Slim Clip Applier Forceps

FDA 510(k) K173271 · Aesculap, Inc.

Substantially Equivalent

510(k) numberK173271

Submission

Device name
Aesculap Slim Clip Applier Forceps
Applicant
Aesculap, Inc.
Center Valley, PA, US
Received
October 12, 2017
Decision date
November 10, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCI – Applier, Aneurysm Clip
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4175
Specialty
Neurology

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K180914Aesculap Slim Clip ApplierHCI · Traditional Aesculap, Inc.04/17/2018SE
K010910Medicon Yasargil Clip Applying ForcepsHCI · Traditional Medicon EG08/01/2001SE
K994191Spetzler Round Handle Appliers, Models C-3753, C-3753T, C-3754, C-3754THCI · Traditional Nmt Medical, Inc.02/08/2000SE
K984109Aesculap Axial Clip ApplierHCI · Traditional Aesculap, Inc.02/12/1999SE
K982379Sundt Slim-Line Aneurysm Clip ApplierHCI · Traditional Johnson & Johnson Professionals, Inc.12/18/1998SE
K954658Perneczky Clip Applier/RemoverHCI · Traditional Von Zeppelin GmbH10/08/1996SE
K940970Yasargil, Caspar, Vario Clip AppliersHCI · Traditional Aesculap, Inc.01/24/1995SE
K902544Sundt Avm Micro ClipHCI · Traditional Codman & Shurtleff, Inc.09/20/1990SE

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Questions and answers

When was Aesculap Slim Clip Applier Forceps cleared by the FDA?

Aesculap Slim Clip Applier Forceps (K173271) received a 510(k) decision of Substantially Equivalent on November 10, 2017, 29 days after the submission was received.

What is the product code of K173271?

The FDA product code is HCI – Applier, Aneurysm Clip, a Class II (moderate risk) device regulated under 21 CFR 882.4175.