510(k) K143024

Device: CAS-One Liver
Applicant: CAScination AG
510(k) number: K143024
Product code: OEW
Decision: Substantially Equivalent (SESE)
Decision date: 2015-04-28
Date received: 2014-10-21
Regulation: 882.4560
Classification name: Tracking, Soft Tissue, Intraoperative
Medical specialty: Neurology
Review panel: General & Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Matthias Peterhans
Address: Stauffacherstrasse 78 Bern CH 3014 3014

FDA Registration Numbers#

1721676
1018470
3010280625
1222780
3007015148
3006330030
3011797532

Source Documents#

Other 510(k) Records For Product Code OEW #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K101979	EXPLORER LIVER (PASSIVE TRACKING)	Pathfinder Therapeutics, Inc.	2011-02-09
K093494	LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM	Pathfinder Therapeutics, Inc.	2010-03-30
K071063	LINASYS	Pathfinder Therapeutics, Inc.	2007-12-20

Legacy Summary#

summary

FDA Review#

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