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This document provides a summary of the 510(k) premarket notification for the Intra Operative Probe (10P8) manufactured by Huntleigh Healthcare. It details the device's classification, indications

How to fill out intra operative probe 10p8

How to fill out Intra Operative Probe (10P8) 510(k) Summary

1. Gather all necessary information about the Intra Operative Probe (10P8) including its intended use.
2. Identify and describe the device characteristics including design, material, and specifications.
3. Outline the premise for substantial equivalence with existing devices specifying differences and similarities.
4. Include clinical data if available, detailing the safety and effectiveness of the probe.
5. Provide labeling information, including instructions for use and any warnings.
6. Detail the manufacturing process and quality control measures.
7. Summarize the testing performed, including biocompatibility and performance tests.
8. Review and compile all supporting documents and citations.
9. Complete the 510(k) form as required by the FDA.
10. Submit the summary along with all required documentation to the FDA for review.

Who needs Intra Operative Probe (10P8) 510(k) Summary?

1. Medical device manufacturers looking to bring an intraoperative probe to market.
2. Healthcare professionals seeking to understand the regulatory status of the probe.
3. Regulatory affairs specialists involved in compliance with FDA regulations.
4. Investors and stakeholders interested in the medical device market.

People Also Ask about

What is the meaning of intraoperative use?

The intraoperative phase of surgery is when your patient undergoes a surgical procedure, beginning when they enter the operating room and ending when they leave the operating room.

What is an intraoperative ultrasound?

A procedure that uses ultrasound (high-energy sound waves that are bounced off internal tissues and organs) during surgery. Sonograms (pictures made by ultrasound) of the inside of the body are viewed on a computer to help a surgeon find tumors or other problems during the operation. Also called IOUS.

What is intraoperative probe?

An intraoperative probe consists of a detector, collimator, digital or analog display, and an audio signal generator. At present, commercially available probes have either a NaI or CsI scintillation crystal or a CdZnTe or CdTe semiconductor detector.

What does a probe do in surgery?

The Probe enables the surgeon to easily insert an instrument through a small stab incision in soft tissue with the tip in a straight position. The tip of the probe can then be changed to a locked 90˚ position to test the strength of a soft tissue repair or to probe defects.

What are the uses of intraoperative probe?

Intraoperative gamma probes have been used in procedures for the removal of benign tumors such as osteoid osteoma and parathyroid adenoma and for removing malignant brain and colorectal tumors.

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What is Intra Operative Probe (10P8) 510(k) Summary?

The Intra Operative Probe (10P8) 510(k) Summary is a document submitted to the FDA that provides evidence that a new medical device is safe and effective for its intended use, specifically for intraoperative applications in medical procedures.

Who is required to file Intra Operative Probe (10P8) 510(k) Summary?

Manufacturers and importers of the Intra Operative Probe (10P8) are required to file a 510(k) Summary with the FDA to market their devices in the United States.

How to fill out Intra Operative Probe (10P8) 510(k) Summary?

To fill out the Intra Operative Probe (10P8) 510(k) Summary, applicants must provide information including device description, intended use, indications for use, technological characteristics, performance data, and substantial equivalence to a legally marketed device.

What is the purpose of Intra Operative Probe (10P8) 510(k) Summary?

The purpose of the Intra Operative Probe (10P8) 510(k) Summary is to demonstrate to the FDA that the medical device is equivalent to an existing, legally marketed device, ensuring its safety and effectiveness for use in surgical procedures.

What information must be reported on Intra Operative Probe (10P8) 510(k) Summary?

The Intra Operative Probe (10P8) 510(k) Summary must report information including device name, manufacturer details, intended use, design specifications, labeling, and results of any clinical or nonclinical testing relevant to the device's safety and effectiveness.