Home / 510(k) Clearances / K171534

510(k) K171534

SurgicalPreview by Endo Vantage, LLC — Product Code PZO

K171534 is an FDA 510(k) premarket notification submitted by Endo Vantage, LLC for the device "SurgicalPreview". The FDA issued a decision of Substantially Equivalent on November 8, 2017. The device falls under product code PZO (Software For Visualization Of Vascular Anatomy And Intravascular Devices), a Class II device regulated under 21 CFR 892.2050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2017
Date Received
May 25, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Software For Visualization Of Vascular Anatomy And Intravascular Devices
Device Class
Class II
Regulation Number
892.2050
Review Panel
CV
Submission Type

Visualization and measurement of blood vessels and intravascular devices for preoperational planning.

Other clearances for product code PZO

  • K253122 — Sim&Size (December 23, 2025)
  • K250160 — ANKYRAS (May 6, 2025)
  • K242124 — Sim&Size (December 14, 2024)
  • K230006 — Ankyras (December 28, 2023)
  • K222664 — Sim&Size (January 27, 2023)
  • K213838 — AneuGuide (June 1, 2022)
  • K212373 — Sim&Size (January 27, 2022)
  • K202322 — Sim&Size (December 31, 2020)
  • K190049 — Sim&Size (September 17, 2019)

FDA data resources