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Este documento resume la información sobre el Freedom Inguinal Hernia Implant, un dispositivo médico utilizado para reforzar tejidos blandos donde existe debilidad para la reparación abierta de

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How to fill out Freedom Inguinal Hernia Implant 510(k) Summary

1. Gather all necessary product information and specifications for the Freedom Inguinal Hernia Implant.
2. Compile clinical data supporting the safety and effectiveness of the implant.
3. Prepare a detailed description of the implant’s design, materials, and manufacturing processes.
4. Include labeling and packaging information that complies with FDA regulations.
5. Document adverse event reporting and any previous submissions related to the implant.
6. Complete the FDA 510(k) form with all mandatory fields filled out accurately.
7. Review the entire summary for clarity and accuracy before submission.

Who needs Freedom Inguinal Hernia Implant 510(k) Summary?

1. Manufacturers of the Freedom Inguinal Hernia Implant seeking FDA clearance.
2. Regulatory professionals and compliance teams involved in product development.
3. Healthcare professionals needing detailed information on the implant's safety and efficacy.
4. Investors or stakeholders interested in market entry and product validation.

People Also Ask about

Is CT or MRI better for inguinal hernia?

Magnetic resonance imaging (MRI) is a highly accurate imaging modality for diagnosing hernias.

What is the best imaging for a direct inguinal hernia?

Ultrasonography, which is the first-line imaging modality, has a sensitivity of 33% to 86% and specificity of 77% to 90% for occult hernias and can be used to diagnose suspected groin hernias not evident on clinical examination.

What is the rule of 6 for inguinal hernia?

Transection of round ligament is then recommended, at least 1 cm proximal the deep ring in order avoid injury of genital branch of the genitofemoral nerve at this location. Rule 6: In large or inguino-scrotal hernias, it is recommended to transect and abandon the distal hernia sac within the .

What is the best imaging test for inguinal hernia?

MRI is superior to ultrasonography and computed tomography in diagnosing inguinal hernias, particularly occult hernias.

What is the recurrence rate of tension free inguinal hernia repairs with mesh?

The type of surgery that was used to perform the repair is also a factor. The risk of developing a recurrent hernia after an open tension free mesh repair is around 0.5 – 1% compared to a risk of 2-5 % for a laparoscopic or keyhole repair.

What is the gold standard for inguinal hernia imaging?

Surgeons from Vanderbilt University are recommending that dynamic abdominal sonography for hernia (DASH) replace computed tomography (CT) as the gold standard for the radiographic identification and characterization of incisional hernia.

What is the recurrence rate of tension free inguinal hernia repair with mesh?

The reported recurrence rate for inguinal herniorrhaphy ranges from 0.5% to 15%, and associated factors for recurrence include the herniorrhaphy method, patient compliance, and the surgeon's experience [19,20]. Compared with traditional tension repair, tension-free mesh herniorrhaphy has a recurrence rate of <2% [36].

How long does an inguinal hernia mesh repair last?

Hernia Recurrence Elective repair of an inguinal hernia has a low rate of recurrence overall. Recurrence with mesh repair is lower compared to recurrence with suture repair with rates of 3% to 5% and 10% to 15% respectively.

What is the best way to image an inguinal hernia?

Computed tomography (CT) and magnetic resonance imaging are regarded as problem-solving tools to be used after US. In older male patients, direct inguinal hernia with herniation of peritoneal is incidentally seen on abdominal and pelvic CT scans.

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What is Freedom Inguinal Hernia Implant 510(k) Summary?

The Freedom Inguinal Hernia Implant 510(k) Summary is a document submitted to the FDA that outlines information about a specific medical device, intended to demonstrate that the device is safe and effective for its intended use.

Who is required to file Freedom Inguinal Hernia Implant 510(k) Summary?

Manufacturers of the Freedom Inguinal Hernia Implant are required to file the 510(k) Summary to obtain clearance from the FDA before marketing the device.

How to fill out Freedom Inguinal Hernia Implant 510(k) Summary?

Filling out the Freedom Inguinal Hernia Implant 510(k) Summary involves providing details such as a description of the device, its intended use, a comparison with similar devices, and results of any clinical studies or tests.

What is the purpose of Freedom Inguinal Hernia Implant 510(k) Summary?

The purpose of the Freedom Inguinal Hernia Implant 510(k) Summary is to demonstrate that the device is substantially equivalent to a legally marketed predicate device and to ensure its safety and effectiveness.

What information must be reported on Freedom Inguinal Hernia Implant 510(k) Summary?

The information that must be reported includes device name, intended use, description, labeling, manufacturing details, performance data, and any clinical or non-clinical testing results.