FDA product code ORR: Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
ORR is the FDA product code for neurological stereotaxic instrument, real-time intraoperative mri. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Neurology panel. FDA has cleared 4 510(k) submissions under ORR, from 3 different applicants. The average 510(k) review took 126 days (median 130).
Definition
To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
Classification
| Field | Value |
|---|---|
| Device name | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for ORR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 175 |
| 2018 | 1 | 182 |
Compare with all 510(k) review times · Search every ORR clearance
Top ORR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mri Interventions, Inc. | 2 | 2018-11-02 |
| Surgi-Vision, Inc. | 1 | 2011-06-22 |
| Surgivision, Inc. | 1 | 2010-06-16 |
Most recent ORR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181195 | Mri Interventions, Inc. | ClearPoint System | 2018-11-02 | 182 |
| K171257 | Mri Interventions, Inc. | ClearPoint System | 2017-10-20 | 175 |
| K111073 | Surgi-Vision, Inc. | SURGIVISION INC. CLEARPOINT SYSTEM | 2011-06-22 | 65 |
| K100836 | Surgivision, Inc. | CLEARPOINT SYSTEM | 2010-06-16 | 84 |
Recalls for ORR devices
openFDA lists no recalls for product code ORR.
Frequently asked questions
What is FDA product code ORR?
ORR is the FDA product code for neurological stereotaxic instrument, real-time intraoperative mri. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Neurology panel.
What device class is ORR?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code ORR?
Across 4 cleared submissions the average was 126 days from receipt to decision (median 130).
Which companies have the most ORR clearances?
Mri Interventions, Inc. (2); Surgi-Vision, Inc. (1); Surgivision, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ORR
- Run a recall and safety report across every ORR manufacturer
- Watch product code ORR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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