Home / 510(k) Clearances / K113533

510(k) K113533

NEURO CHECK DEVICE WITH IO-FLEX WIRE by Baxano, Inc. — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2012
Date Received
November 30, 2011
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)
  • K110696 — NEURO CHECK DEVICE WITH IO-FLEX WIRE (July 7, 2011)
  • K102594 — IO-FLEX CATHETER (January 19, 2011)
  • K100958 — MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES (July 23, 2010)
  • 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)

Other clearances for product code HAE

  • K242759 — Geister K-Rex rongeurs (June 6, 2025)
  • K223596 — SQ.line KERRISON (June 29, 2023)
  • K230256 — Rebellion, Phantom Multi-Bite Kerrison Rongeur (March 3, 2023)
  • 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)