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510(k) K902818

MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT by Ruggles Corp. — Product Code HBG

K902818 is an FDA 510(k) premarket notification submitted by Ruggles Corp. for the device "MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT". The FDA issued a decision of Substantially Equivalent on September 20, 1990. The device falls under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)), a Class II device regulated under 21 CFR 882.4300. Ruggles Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1990
Date Received
June 27, 1990
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 Ruggles Corp.

  • K903485 — TITANIUM MESH (February 21, 1991)
  • K902819 — LAMINECTOMY ROGEUR (August 9, 1990)
  • K902850 — ZEPPELIN INSTRUMENTS (July 18, 1990)
  • K893415 — TRANS-ORAL DEPTH GAUGE (June 7, 1989)

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)
  • K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILL (June 5, 1996)
  • K932402 — MODIFICATION TO GHAJAR GUIDE TWIST DRILL (August 5, 1993)

FDA data resources