SI Ascope

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K011273 ↗

FDA Product Code

PSN

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Siascope II

  Class II

  FDA 510(k) K023729 Active Cleared 3 Feb 2003

• Siascope V

  Class II

  FDA 510(k) K062736 Active Cleared 14 Sep 2007

• What types of surgical procedures is the SI Ascope primarily used for, and why is it beneficial in those settings?

  The SI Ascope is designed for use in plastic and general surgery procedures where clear visualisation of tissue surfaces is essential. Its optical technology enhances visibility of anatomical structures, helping surgeons achieve greater precision during delicate operations. This is particularly useful in procedures requiring meticulous tissue handling, such as reconstructive or cosmetic surgeries, where accuracy can directly impact outcomes.

• Is the SI Ascope a single-use or reusable device, and what maintenance steps are required to ensure its safe repeated use?

  The SI Ascope is a reusable instrument, intended for use in controlled clinical settings like operating rooms. To maintain safety and performance, it must follow manufacturer-provided sterility and maintenance protocols. These protocols likely include cleaning, disinfection, and periodic inspections to prevent contamination or damage, ensuring reliable use across multiple procedures.

• How is the SI Ascope regulated in the U.S., and what does the ‘Substantially Equivalent’ determination mean for its use?

  The SI Ascope has received FDA 510(k) clearance under the ‘Substantially Equivalent’ determination (K011273), meaning it has been deemed comparable to a legally marketed predicate device in terms of technology and safety. This classification ensures it meets regulatory standards for light-based imaging devices (Product Code PSN) under FDA regulation 878.4580, allowing its use in clinical settings with confidence in its performance and compliance.

• What regulatory body or committee reviewed the SI Ascope’s submission, and what was the decision outcome?

  The SI Ascope’s submission was reviewed by the FDA’s Surgical and Urological Devices (SU) Advisory Committee. The decision outcome was a ‘Substantially Equivalent’ (SESE) determination, confirming it meets the safety and effectiveness criteria for existing predicate devices in its category, enabling its commercial distribution and use in approved clinical applications.