← Back to catalogue

Stryker 8000 Surgery Stretcher

FDA 510(k)

Class II (US FDA 510(k))

510(k) K943864

by Stryker Medical

Identifiers

510(k) Number
K943864 FDA 510(k)
FDA Product Code
FPO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6910 FDA 510(k)
Regulation Number
880.6910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Stryker 8000 Surgery Stretcher is a wheeled, patient transport device designed for safe and efficient movement of patients within clinical settings. It falls under the classification of a stretcher, intended for use in general hospital environments, including operating rooms, emergency departments, and recovery areas. Its primary function is to support and transport patients while maintaining stability and comfort during transfers.

This device is supplied as a reusable medical instrument, intended for use in sterile or semi-sterile environments depending on clinical protocol. It features a weight capacity of 660 pounds and an extra-wide patient surface measuring 31 inches, enhancing patient safety and comfort. The stretcher is regulated under FDA 510(k) clearance (K943864) and classified as a Class II device, adhering to regulatory standards for general hospital use. Storage and maintenance should follow manufacturer guidelines to ensure proper functionality and hygiene.

Frequently asked questions

What environments is the Stryker 8000 Surgery Stretcher intended for use in, and how does its design support patient safety and comfort during transport?

The Stryker 8000 Surgery Stretcher is designed for general hospital environments, including operating rooms, emergency departments, and recovery areas. Its extra-wide patient surface (31 inches) and high weight capacity (660 pounds) enhance stability and comfort, ensuring safe and secure patient transport during transfers.

Is the Stryker 8000 Surgery Stretcher intended for single-use or reusable applications, and what considerations should be taken for its maintenance?

The Stryker 8000 Surgery Stretcher is a reusable medical device, intended for use in sterile or semi-sterile environments based on clinical protocols. Proper storage and maintenance, as outlined by the manufacturer, are essential to ensure functionality, hygiene, and longevity of the device.

What regulatory pathway was followed for the Stryker 8000 Surgery Stretcher, and what does this mean for its use in clinical settings?

The Stryker 8000 Surgery Stretcher was cleared through the FDA’s 510(k) pathway (K943864) as a Class II device, demonstrating it meets regulatory standards for general hospital use. This clearance indicates it has been evaluated for safety and effectiveness in its intended clinical applications, such as patient transport in operating rooms and recovery areas.

How does the Stryker 8000 Surgery Stretcher differ from standard stretchers in terms of patient support and mobility?

The Stryker 8000 Surgery Stretcher stands out with its extra-wide patient surface (31 inches) and high weight capacity (660 pounds), which provide superior stability and comfort compared to standard stretchers. Its wheeled design ensures smooth mobility, making it ideal for transferring patients safely across diverse hospital settings like ORs, ERs, and recovery rooms.

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: Stretchers and transport chairs - Stryker, Hillrom 8000 - Agility Surgical Consultants, Jobs and Careers at Stryker | Stryker Careers, HILL-ROM TRANSTAR STRETCHER P8000 - orsupport.com, Stretcher Products - Stryker Corporation

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Stryker Medical

Sources (1)

  • FDA 510(k) K943864 24 fields · synced Sep 19, 2026