Get the free STERIS Traditional 510(k) PREMARKET NOTIFICATION

Description of Device The VERIFY V24 Self-Contained Biological Indicator SCRI is used by healthcare providers to monitor the V-PRO Low Temperature Sterilization Systems and the STERRAD IOOS STERRAD 200 STERRAD NX and STERRAD IOONX Express Standard and Flex Scope Cycles Sterilizers. 2800 FRC Class 11 Predicate Device Verify Self-Contained Biological Indicator SCRI for Vaporized H20 Sterilization Processes K073244 modified under K0905 14. 000 June 16 2014 William Brodbeck Ph. D Trade/Device...

How to fill out steris traditional 510k premarket

How to fill out steris traditional 510k premarket

1. Gather all necessary information about the device and its intended use.
2. Download the Steris Traditional 510(k) Premarket Notification submission form from the FDA website.
3. Fill out the form by providing detailed information about the device, its components, and its intended use.
4. Include any necessary supporting documents and data to demonstrate the safety and effectiveness of the device.
5. Submit the completed form and supporting documents to the FDA for review.
6. Wait for the FDA to review the submission and provide feedback or approval.

Who needs steris traditional 510k premarket?

1. Medical device manufacturers who intend to market a new medical device in the United States.
2. Companies seeking clearance from the FDA to sell a device that is substantially equivalent to a legally marketed device.
3. Individuals or organizations responsible for ensuring compliance with FDA regulations regarding medical devices.
4. Any entity involved in the design, manufacturing, or distribution of medical devices in the United States.

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What is steris traditional 510k premarket?

Steris traditional 510k premarket is a regulatory submission to the FDA that demonstrates a medical device is safe and effective for its intended use.

Who is required to file steris traditional 510k premarket?

Manufacturers of medical devices seeking FDA approval to market their products in the United States.

How to fill out steris traditional 510k premarket?

The submission must include detailed information about the device, its intended use, comparisons to similar devices on the market, and scientific data supporting its safety and effectiveness.

What is the purpose of steris traditional 510k premarket?

The purpose is to demonstrate to the FDA that the medical device is substantially equivalent to a legally marketed device and does not raise any new issues of safety or effectiveness.

What information must be reported on steris traditional 510k premarket?

Information such as device description, intended use, substantial equivalence, performance testing, biocompatibility, software validation, and clinical data if applicable.