Manual Cranial Drill, Burr, Trephine & Accessories
FDA 510(k) K874952 · Solway, Inc.
510(k) numberK874952
Submission
- Device name
- Manual Cranial Drill, Burr, Trephine & Accessories
- Applicant
- Solway, Inc.
Hollywood, FL, US - Received
- December 2, 1987
- Decision date
- December 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K252696 | LegacyHBG · Traditional | Phasor Health, LLC | 11/21/2025SE |
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| K162884 | SpineGuard DSG Zavation Screw SystemHBG · Traditional | Spineguard S.A. | 01/12/2017SE |
| K160129 | MRII Cranial Drill and AccessoriesHBG · Special | Mri Interventions, Inc. | 03/26/2016SE |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special | Mri Interventions, Inc. | 07/08/2015SE |
| K122456 | Mrii Crainial DrillHBG · Traditional | Mri Interventions, Inc. | 03/22/2013SE |
| K022712 | Hand Drill, Model 11-9901-7HBG · Traditional | Medical Design, LLC | 11/12/2002SE |
| K022370 | Framelock; Framelock AccessoriesHBG · Traditional | Medtronic Xomed, Inc. | 10/18/2002SE |
| K961113 | CNS Interchangeable Bit Cranial DrillHBG · Traditional | Clinical Neuro Systems, LLC | 06/05/1996SE |
| K932402 | Modification to Ghajar Guide Twist DrillHBG · Traditional | Neurodynamics, Inc. | 08/05/1993SE |
More from Neurodynamics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874960 | Cardiovascular Surgical InstrumentsDWS · Traditional | 02/05/1988SE |
| K874962 | Forceps Cliprack Ventricular Cannula Saws SpatulasHAO · Traditional | 02/02/1988SE |
| K874956 | Self-Retaining Retractor for NeurosurgeryGZT · Traditional | 01/28/1988SE |
| K874964 | Dental Hand InstrumentsEKJ · Traditional | 01/27/1988SE |
| K875043 | Rongeur (Neurosurgical Instruments)HAE · Traditional | 01/22/1988SE |
| K874966 | Tuning ForksGWX · Traditional | 01/04/1988SE |
| K874965 | Manual Surgical Instruments for General UseHTD · Traditional | 12/30/1987SE |
| K874961 | Bone Cutting Instruments & AccessoriesGDR · Traditional | 12/30/1987SE |
| K874959 | Vascular ClampHXD · Traditional | 12/30/1987SE |
| K874954 | Manual RongeurHTX · Traditional | 12/30/1987SE |
Questions and answers
When was Manual Cranial Drill, Burr, Trephine & Accessories cleared by the FDA?
Manual Cranial Drill, Burr, Trephine & Accessories (K874952) received a 510(k) decision of Substantially Equivalent on December 30, 1987, 28 days after the submission was received.
What is the product code of K874952?
The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.