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510(k) K180914

Device
Aesculap Slim Clip Applier
Applicant
Aesculap, Inc.
510(k) number
K180914
Product code
HCI  
Decision
Substantially Equivalent (SESE)
Decision date
2018-04-17
Date received
2018-04-09
Regulation
882.4175
Classification name
Applier, Aneurysm Clip
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Paul Amudala
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HCI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221524Sugita AVM Microclip ApplierMizuho America, Inc.2022-06-24
K211572Aesculap Slim Clip ApplierAesculap, Inc.2021-12-13
K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc.2017-11-10
K010910MEDICON YASARGIL CLIP APPLYING FORCEPSMedicon EG2001-08-01
K994191SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754TNmt Medical, Inc.2000-02-08
K984109AESCULAP AXIAL CLIP APPLIERAesculap, Inc.1999-02-12
K982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERJohnson & Johnson Professionals, Inc.1998-12-18
K954658PERNECZKY CLIP APPLIER/REMOVERVon Zeppelin GmbH1996-10-08
K940970YASARGIL, CASPAR, VARIO CLIP APPLIERSAesculap, Inc.1995-01-24
K902544SUNDT AVM MICRO CLIPCodman & Shurtleff, Inc.1990-09-20
K881911NEW SIZES SUGITA CLIPSDowns Surgical , Ltd.1988-06-06
K881912SANO CLIP APPLIERS & REMOVERSDowns Surgical , Ltd.1988-06-06
K833651CLIP APPLYING FORCEPSAdvanced Biosearch Assn.1983-11-29

Legacy Summary#

summary

FDA Review#

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