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ULTRA Telescopes

FDA 510(k)

Class II (US FDA 510(k))

510(k) K160249

by Olympus Winter & Ibe GmbH

Identifiers

510(k) Number
K160249 FDA 510(k)
FDA Product Code
HRX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.1100 FDA 510(k)
Regulation Number
888.1100 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ULTRA Telescopes are rigid endoscopes designed for endoscopic visualization in minimally invasive surgical procedures. These devices provide high-resolution imaging for procedures within the thoracic, peritoneal, and female reproductive cavities, enabling precise surgical navigation and assessment.

These telescopes are supplied as reusable medical devices and are intended for use in sterile surgical settings. They are available in various diameters, including 4 mm and 10 mm, with different angular fields (e.g., 0° and 30°). The devices are regulated under FDA 510(k) clearance (K160249) and are classified under the Orthopedic advisory committee (OR) with a product code of HRX. No specific MRI safety information is provided in the available data.

Frequently asked questions

Are the ULTRA Telescopes designed for single-use or reusable applications in surgery?

The ULTRA Telescopes are explicitly labeled as reusable medical devices, meaning they are intended for repeated use in sterile surgical settings after proper cleaning, disinfection, and sterilization. This design aligns with their use in minimally invasive procedures where durability and repeated imaging are required.

What types of surgical cavities can the ULTRA Telescopes be used to visualize, and what diameters are available?

The ULTRA Telescopes are engineered for endoscopic visualization in the thoracic, peritoneal, and female reproductive cavities, enabling precise surgical navigation. They come in two primary diameters: 4 mm and 10 mm, which cater to different procedural needs and anatomical constraints.

How do I determine which angular field (e.g., 0° or 30°) is best suited for my procedure?

The angular field of the ULTRA Telescopes (e.g., 0° or 30°) is selected based on the specific surgical requirements and anatomical access. A 0° field provides a straight-forward view, ideal for direct visualization, while a 30° field offers angled imaging, useful for navigating tighter or curved spaces. The choice depends on the procedure’s demands and the surgeon’s preference for field of view.

What regulatory pathway was followed for the ULTRA Telescopes, and how is their safety classification determined?

The ULTRA Telescopes were cleared through the FDA’s 510(k) process under Traditional Review, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). They fall under the Orthopedic (OR) Advisory Committee and are classified with the product code HRX, indicating their regulatory classification is based on their intended use in endoscopic visualization rather than orthopedic implants.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Telescope "ULTRA ..., MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "ULTRA ..., ULTRA Telescopes by OLYMPUS WINTER & IBE GMBH | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (1)

  • FDA 510(k) K160249 24 fields · synced Sep 20, 2026