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510(k) K171947

SOLOASSIST II by Aktormed GmbH — Product Code NAY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2018
Date Received
June 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Surgical, Computer Controlled Instrument
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Aktormed GmbH

  • K233312 — SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo (August 8, 2024)
  • K232405 — ENDOFIX EXO (April 25, 2024)
  • K200473 — SoloAsisst II, Voice Control (December 22, 2020)

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  • K252675 — da Vinci SP Surgical System (SP1098) (December 15, 2025)
  • K252069 — da Vinci SP Surgical System (SP1098) (December 2, 2025)
  • K251426 — da Vinci SP Surgical System (SP1098) (October 3, 2025)
  • K251817 — da Vinci SP Surgical System (SP1098) (September 10, 2025)
  • K251227 — da Vinci Surgical System (IS5000) (September 8, 2025)
  • K251324 — da Vinci SP Surgical System (SP1098) (August 29, 2025)
  • K252350 — da Vinci SP Firefly Imaging System (August 28, 2025)