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510(k) K233312

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 by Aktormed GmbH — Product Code QZB

K233312 is an FDA 510(k) premarket notification submitted by Aktormed GmbH for the device "SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894". The FDA issued a decision of Substantially Equivalent on August 8, 2024. The device falls under product code QZB (Software Controlled Endoscope And Instrument Holder), a Class II device regulated under 21 CFR 876.1500. Aktormed GmbH has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2024
Date Received
September 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Software Controlled Endoscope And Instrument Holder
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

To hold and position endoscopes and instruments.

Other clearances by Aktormed GmbH

  • K232405 — ENDOFIX EXO (April 25, 2024)
  • K200473 — SoloAsisst II, Voice Control (December 22, 2020)
  • K171947 — SOLOASSIST II (September 21, 2018)

Other clearances for product code QZB

  • K250984 — Maestro System (REF100) (June 27, 2025)
  • K242323 — Maestro System (REF100) (March 14, 2025)

FDA data resources