510(k) K181195

Device: ClearPoint System
Applicant: MRI Interventions, Inc.
510(k) number: K181195
Product code: ORR
Decision: Substantially Equivalent (SESE)
Decision date: 2018-11-02
Date received: 2018-05-04
Regulation: 882.4560
Classification name: Neurological Stereotaxic Instrument, Real-time Intraoperative Mri
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Pete Piferi
Address: 5 Musick Irvine CA US 92618 92618

FDA Registration Numbers#

2029275
2011171

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00850359007003	ClearPoint	Clearpoint Neuro, Inc.	2022-03-09
00850359007768	ClearPoint	Clearpoint Neuro, Inc.	2021-01-22
00850359007751	ClearPoint	Clearpoint Neuro, Inc.	2021-01-22
08503590070764	ClearPoint	CLEARPOINT NEURO, INC.	2019-05-13
08503590070757	ClearPoint	CLEARPOINT NEURO, INC.	2018-12-12

Other 510(k) Records For Product Code ORR #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K171257	ClearPoint System	Mri Interventions, Inc.	2017-10-20
K111073	SURGIVISION INC. CLEARPOINT SYSTEM	Surgi-Vision, Inc.	2011-06-22
K100836	CLEARPOINT SYSTEM	Surgivision, Inc.	2010-06-16

Legacy Summary#

summary

FDA Review#

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