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510(k) K232405

ENDOFIX EXO by Aktormed GmbH — Product Code OCV

K232405 is an FDA 510(k) premarket notification submitted by Aktormed GmbH for the device "ENDOFIX EXO". The FDA issued a decision of Substantially Equivalent on April 25, 2024. The device falls under product code OCV (Endoscope 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
April 25, 2024
Date Received
August 10, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Holder
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To hold endoscope in a desired position during procedures.

Other clearances by Aktormed GmbH

  • K233312 — SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo (August 8, 2024)
  • K200473 — SoloAsisst II, Voice Control (December 22, 2020)
  • K171947 — SOLOASSIST II (September 21, 2018)

Other clearances for product code OCV

  • K240506 — KARL STORZ Holders (October 22, 2024)
  • K190576 — WalterLorenz Surgical Assist Arm Scope Holder (June 5, 2019)
  • K102179 — ENVIEW (TM) (December 2, 2010)
  • K093616 — V. MUELLER CAMERA CONTROLLER WITH STORAGE CART (December 23, 2009)
  • K992006 — NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 (August 17, 1999)
  • K990334 — KSEA ENDOSCOPE HOLDER (March 22, 1999)
  • K971584 — CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) (May 23, 1997)
  • K960068 — SH-1 SURGICAL HOLDER FOR TELESCOPE (May 5, 1997)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)

FDA data resources