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Os-1 Occlusion System - 1

FDA 510(k)

Class II (US FDA 510(k))

510(k) K894839

by Medical, Inc.

Identifiers

510(k) Number
K894839 FDA 510(k)
FDA Product Code
BZC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1880 FDA 510(k)
Regulation Number
868.1880 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The OS-1 Occlusion System is a medical device classified under FDA regulation 868.1880, designed for use in anesthesiology procedures. It functions as an occlusion device, intended to temporarily obstruct blood flow in specific vascular regions during surgical interventions.

This device is supplied as a reusable medical instrument and has received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent. It is intended for use in controlled clinical settings, adhering to regulatory standards for anesthesia-related applications. The system is categorized under Product Code BZC and was reviewed by the Anesthesiology Advisory Committee.

Frequently asked questions

What is the OS-1 Occlusion System used for?

The OS-1 Occlusion System is designed for use in anesthesiology procedures to temporarily obstruct blood flow in specific vascular regions during surgical interventions. This allows controlled manipulation of blood flow, which can be critical for maintaining patient stability and ensuring surgical precision.

Is the OS-1 Occlusion System reusable or single-use?

The OS-1 Occlusion System is supplied as a reusable medical instrument. Reusability is common for devices intended for controlled clinical settings, as it allows for proper sterilization and repeated use under strict regulatory guidelines, ensuring consistent performance and cost-effectiveness for healthcare providers.

What regulatory pathway was followed for the OS-1 Occlusion System?

The OS-1 Occlusion System received FDA 510(k) clearance through the Traditional pathway, with a decision of Substantially Equivalent (SESE). This pathway confirms that the device is at least as safe and effective as a legally marketed predicate device, adhering to FDA regulations under Product Code BZC for occlusion devices in anesthesiology.

Which advisory committee reviewed the OS-1 Occlusion System?

The OS-1 Occlusion System was reviewed by the Anesthesiology Advisory Committee (AN) as part of its FDA 510(k) clearance process. Advisory committees provide expert input to ensure devices meet clinical and safety standards specific to their intended use, particularly in specialized fields like anesthesiology.

What is the intended clinical setting for the OS-1 Occlusion System?

The OS-1 Occlusion System is intended for use in controlled clinical settings, such as operating rooms or specialized procedure rooms where anesthesiology procedures are performed. Its design and regulatory clearance ensure it meets stringent standards for safety and efficacy in these environments, where precise control of vascular occlusion is essential.

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: OS-1 OCCLUSION SYSTEM - 1 (K894839) — FDA 510(k) | Innolitics, PDF K894839 OS-1 OCCLUSION SYSTEM - 1 - 510kdatabase.net, Os-1 Occlusion System - 1 - Beudamed, COBRA-OS - Front Line Medical Technologies

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical, Inc.

Sources (1)

  • FDA 510(k) K894839 24 fields · synced Oct 1, 2026