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510(k) K930229

CLINICAL NEURO SYSTEMS CRANIAL DRILL by Clinical Neuro Systems, LLC — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1993
Date Received
January 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type

Other clearances by Clinical Neuro Systems, LLC

  • K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILL (June 5, 1996)
  • 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 HBE

  • K250815 — Hubly Drill (H100) (November 6, 2025)
  • K252060 — GREEN (October 31, 2025)
  • K252662 — UniBur (September 19, 2025)
  • K251433 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070 (June 4, 2025)
  • K250380 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.0 (March 13, 2025)
  • K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision (March 11, 2025)
  • K232684 — Surgify Halo (November 29, 2023)
  • K230619 — Hubly Electric Drill (H100) (May 4, 2023)
  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
  • K213072 — 2.1 x 255mm Drill, 22mm Stop (August 23, 2022)