510(k) K160129
- Device
- MRII Cranial Drill And Accessories
- Applicant
- MRI INTERVENTIONS, INC.
- 510(k) number
- K160129
- Product code
- HBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-03-26
- Date received
- 2016-01-20
- Regulation
- 882.4300
- Classification name
- Drills, Burrs, Trephines & Accessories (manual)
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER PIFERI
- Address
- 5 Musick Irvine CA US 92618 92618
FDA Registration Numbers#
- 3014334038
- 1721676
- 3016577622
- 3013557562
- 3011689956
- 9614945
- 9611112
- 3005809810
- 9710524
- 3028006458
- 3004215117
- 9611274
- 3011137372
- 2031093
- 3005067367
- 3006554912
- 2011171
- 2023988
- 3008102049
- 1417592
- 1836161
- 3015531529
- 3010041511
- 1423714
- 1923569
- 1722447
- 8040233
- 3023852420
- 3034676720
- 8010769
- 9680515
- 2029275
- 3007773213
- 3008868758
- 3003730855
- 3009417901
- 8010405
- 2031917
- 1220477
- 3018094310
- 8044098
- 3009865268
- 8010168
- 8010303
- 3008812560
- 3004608878
- 1043653
- 8030607
- 2183319
- 3003080184
- 8010300
- 3003418325
- 3012507533
- 3015399803
- 8040179
- 8010665
- 2183456
Source Documents#
Other 510(k) Records For Product Code HBG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252696 | LEGACY | Phasor Health, LLC | 2025-11-21 |
| K153587 | Taps for Resorbable Screws | Synthes (USA) Products, LLC | 2017-01-18 |
| K162884 | SpineGuard DSG Zavation Screw System | Spineguard S.A. | 2017-01-12 |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | Mri Interventions, Inc. | 2015-07-08 |
| K122456 | MRII CRAINIAL DRILL | Mri Interventions, Inc. | 2013-03-22 |
| K022712 | HAND DRILL, MODEL 11-9901-7 | Medical Design, LLC | 2002-11-12 |
| K022370 | FRAMELOCK; FRAMELOCK ACCESSORIES | Medtronic Xomed, Inc. | 2002-10-18 |
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL | Clinical Neuro Systems, LLC | 1996-06-05 |
| K932402 | MODIFICATION TO GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | 1993-08-05 |
| K915546 | PS MEDICAL VENTRICULOSTOMY KIT | Pudenz-Schulte Medical Research Corp. | 1991-12-30 |
| K904283 | PS MEDICAL CRANIAL HAND DRILL | Pudenz-Schulte Medical Research Corp. | 1990-10-03 |
| K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | Ruggles Corp. | 1990-09-20 |
| K892531 | NEUROSURGICAL DRILLS: STILLE, HUDSON | Zinnanti Surgical Instruments, Inc. | 1989-05-05 |
| K875018 | GHAJAR GUIDE TWIST DRILL | Neurodynamics, Inc. | 1988-01-28 |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Solway, Inc. | 1987-12-30 |
Legacy Summary#
summary
FDA Review#
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