510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ORRClass II

Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

21 CFR 882.4560 / Neurology
FDA source (opens on fda.gov)

ORR is the FDA product code for Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code reads: "To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ORR
Device name
Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
FDA definition
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code ORR

By decision year
4 clearances under product code ORR with a decision year between 2010 and 2018, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ORR by decision year
YearClearances
20101
20111
20171
20181

Applicants with the most clearances

Product code ORR
Applicants holding the most 510(k) clearances under product code ORR
ApplicantClearances
Mri Interventions, Inc.2
Surgi-Vision, Inc.1
Surgivision, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code