SYMBIS Surgical System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K143420 ↗

FDA Product Code

HAW

Device Class

Class II

Regulation

21 CFR Part 882.4560

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• HFD100 Rocker Arm Accessory

  Class II

  FDA 510(k) K141950 Active Cleared 4 Sep 2014

• Neuro II-Se, Models or-Mb-Dr and or-Dr

  Class II

  FDA 510(k) K061916 Active Cleared 11 Aug 2006

• Ict

  Class II

  FDA 510(k) K130224 Active Cleared 18 Jul 2013

• Imrx

  Class II

  FDA 510(k) K091166 Active Cleared 2 Sep 2009

• Imrx System V1 and Imrisnv/Imriscardio Open recall

  Class II

  FDA 510(k) K101813 Active Cleared 5 Oct 2010

• Neuro III-Sv Open recall

  Class II

  FDA 510(k) K083137 Active Cleared 16 Dec 2008

See all devices from Imris, Inc. →