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510(k) K063468

THE FUGO BLADE FOR DENTISTRY by Medisurg , Ltd. — Product Code EKZ

K063468 is an FDA 510(k) premarket notification submitted by Medisurg , Ltd. for the device "THE FUGO BLADE FOR DENTISTRY". The FDA issued a decision of Substantially Equivalent on April 18, 2007. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920. Medisurg , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2007
Date Received
November 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type

Other clearances by Medisurg , Ltd.

  • K050933 — FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 (December 9, 2005)
  • K041019 — THE FUGO BLADE FOR GLAUCOMA (October 8, 2004)
  • K001498 — THE FUGO BLADE (August 10, 2000)

Other clearances for product code EKZ

  • K213477 — Root ZX3 (August 3, 2022)
  • K071632 — PERFECT TISSUE CONTOURING SYSTEM II (October 18, 2007)
  • K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (December 9, 2005)
  • K050735 — MC6A (May 23, 2005)
  • K023672 — X O ODONTOSURGE 4 (April 29, 2003)
  • K020080 — BONART ART-E1 ELECTROSURGERY UNIT (February 19, 2002)
  • K001560 — ODONTOSURGE 3 (August 24, 2000)
  • K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (April 11, 2000)
  • K982229 — BI-DENT (August 13, 1998)
  • K981390 — ODONTOSURGE 2 (June 11, 1998)

FDA data resources