CNS Interchangeable Bit Cranial Drill
FDA 510(k) K961113 · Clinical Neuro Systems, LLC
510(k) numberK961113
Submission
- Device name
- CNS Interchangeable Bit Cranial Drill
- Applicant
- Clinical Neuro Systems, LLC
Exton, PA, US - Received
- March 20, 1996
- Decision date
- June 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Pudenz-Schulte Medical Research Corp.
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|---|---|---|
| K930229 | Clinical Neuro Systems Cranial DrillHBE · Traditional | 03/16/1993SE |
| K922941 | Clinical Neuro Systems Monitorr Icp Ventricular CaJXG · Traditional | 08/26/1992SE |
| K922936 | Clinical Neuro Systems Monitorr Icp Lumbar CatheteJXG · Traditional | 08/26/1992SE |
| K920156 | Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SyJXG · Traditional | 03/16/1992SE |
Questions and answers
When was CNS Interchangeable Bit Cranial Drill cleared by the FDA?
CNS Interchangeable Bit Cranial Drill (K961113) received a 510(k) decision of Substantially Equivalent on June 5, 1996, 77 days after the submission was received.
What is the product code of K961113?
The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.