Home / 510(k) Clearances / K961113

510(k) K961113

CNS INTERCHANGEABLE BIT CRANIAL DRILL by Clinical Neuro Systems, LLC — Product Code HBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1996
Date Received
March 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Manual)
Device Class
Class II
Regulation Number
882.4300
Review Panel
NE
Submission Type

Other clearances by Clinical Neuro Systems, LLC

  • K930229 — CLINICAL NEURO SYSTEMS CRANIAL DRILL (March 16, 1993)
  • K922936 — CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE (August 26, 1992)
  • K922941 — CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA (August 26, 1992)
  • K920156 — CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY (March 16, 1992)

Other clearances for product code HBG

  • K252696 — LEGACY (November 21, 2025)
  • K153587 — Taps for Resorbable Screws (January 18, 2017)
  • K162884 — SpineGuard DSG Zavation Screw System (January 12, 2017)
  • K160129 — MRII Cranial Drill and Accessories (March 26, 2016)
  • K151536 — SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (July 8, 2015)
  • K122456 — MRII CRAINIAL DRILL (March 22, 2013)
  • K022712 — HAND DRILL, MODEL 11-9901-7 (November 12, 2002)
  • K022370 — FRAMELOCK; FRAMELOCK ACCESSORIES (October 18, 2002)
  • K932402 — MODIFICATION TO GHAJAR GUIDE TWIST DRILL (August 5, 1993)
  • K915546 — PS MEDICAL VENTRICULOSTOMY KIT (December 30, 1991)