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This document summarizes the safety and effectiveness of the Electrosurgical Unit PSD-60 and its accessories, submitted according to SMDA 1990 and FDA regulations.

How to fill out smda 510k summary electrosurgical

How to fill out SMDA 510(k) SUMMARY Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES

1. Gather all necessary information about the Electrosurgical unit PSD-60, including specifications and intended use.
2. Review the FDA guidelines for 510(k) submissions to ensure compliance.
3. Complete the 510(k) application form, providing manufacturer details and device description.
4. Prepare a summary of safety and effectiveness data relevant to the PSD-60 unit and its accessories.
5. Include labeling and promotional materials that will accompany the device.
6. Compile any required user studies or clinical data supporting the device's safety and efficacy.
7. Submit the completed 510(k) application along with the required fees to the FDA.
8. Respond to any requests for additional information from the FDA promptly.

Who needs SMDA 510(k) SUMMARY Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES?

1. Medical device manufacturers seeking to market the Electrosurgical unit PSD-60 and its accessories.
2. Healthcare facilities that wish to purchase or use the Electrosurgical unit PSD-60.
3. Regulatory professionals and compliance officers involved in the approval process of medical devices.

People Also Ask about

What is the 510k summary?

The FDA's database of 510(k) premarket notifications is available for public access on the department's official website.

Are FDA 510 K submissions public?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

Are FDA 510K submissions public?

The FDA's database of 510(k) premarket notifications is available for public access on the department's official website.

What happens after 510k submission?

Once a device receives clearance, a company has 30 days to register the device with the FDA. If the company is new and has no devices on the market, it must also register as an establishment with the FDA, which incurs an annual fee. Some firms are surprised to learn that additional fees are involved in this process.

Are FDA applications public?

FDA stipulates that data and information in an investigational new drug (IND) application are only disclosed consistent with applicable statutes and regulations.

Can you see FDA submissions?

The FDA secures the information about each submission's progress to ensure only the official correspondent or designated delegates* for that submission can view the status.

For pdfFiller’s FAQs

What is SMDA 510(k) SUMMARY Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES?

The SMDA 510(k) SUMMARY for the Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES provides a regulatory framework and safety information regarding a medical device used for electrosurgical procedures. This summary outlines the device's intended use, design, technological characteristics, and claims of substantial equivalence to predicate devices.

Who is required to file SMDA 510(k) SUMMARY Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES?

Manufacturers or importers of the Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES are required to file a 510(k) summary. This includes companies that create, modify, or sell the device in the United States, as they need to demonstrate that their device is safe and effective for its intended use.

How to fill out SMDA 510(k) SUMMARY Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES?

To fill out the SMDA 510(k) SUMMARY, manufacturers must complete specific sections detailing the device, including product information, intended use, technological characteristics, comparisons to predicate devices, safety and efficacy data, labeling information, and any additional information requested by the FDA.

What is the purpose of SMDA 510(k) SUMMARY Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES?

The purpose of the SMDA 510(k) SUMMARY is to provide the FDA with sufficient information to determine whether the Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES can be classified as substantially equivalent to a legally marketed device, ensuring that it meets safety and effectiveness standards.

What information must be reported on SMDA 510(k) SUMMARY Electrosurgical unit PSD-60, ENDOPLASMA, ACCESSORIES?

The information required in the SMDA 510(k) SUMMARY includes device description, intended use, technological characteristics, information on predicate devices, safety and performance data, labeling information, and any unique features or innovations that distinguish the new device from existing ones.