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510(k) K100958

MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES by Baxano, Inc. — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2010
Date Received
April 7, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
Review Panel
NE
Submission Type

Other clearances by Baxano, Inc.

  • K113073 — IO-TOME DEVICE (July 27, 2012)
  • K113533 — NEURO CHECK DEVICE WITH IO-FLEX WIRE (April 11, 2012)
  • K110696 — NEURO CHECK DEVICE WITH IO-FLEX WIRE (July 7, 2011)
  • K102594 — IO-FLEX CATHETER (January 19, 2011)
  • K092729 — BAXANO NEURO CHECK DEVICE (October 2, 2009)
  • K081742 — BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 (September 17, 2008)
  • K080494 — BAXANO ULTRA LOW PROFILE RONGEUR (March 4, 2008)
  • K063231 — MICROBLADE SHAVER AND ACCESSORIES (April 16, 2007)
  • K062711 — ULTRA LOW PROFILE RONGEUR (March 7, 2007)

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  • K221818 — Rebellion; Phantom Multi-Bite Kerrison Rongeur (October 7, 2022)
  • K210741 — KLS Martin Neuro Rongeurs (June 3, 2022)
  • K200768 — Rebellion, Phantom Multi-Bite Kerrison Rongeur (May 4, 2021)
  • K200387 — Ace Medical Surgical Instruments (July 21, 2020)
  • K200383 — Wiggins Medical Surgical Instruments (July 21, 2020)
  • K180949 — Steribite (November 8, 2018)
  • K161744 — Symmetry Sharp Kerrison Rongeur (September 7, 2016)