Get the free ORISE(tm) Tissue Retractor System. Traditional 510(k)

February 9, 2018, Boston Scientific Corporation Thomas Hire Senior Manager, Regulatory Affairs 100 Boston Scientific Way Marlborough, MA 01752Re:K173400 Trade/Device Name: RISE Tissue Retractor System Regulation

How to fill out orisetm tissue retractor system

How to fill out orisetm tissue retractor system

1. Step 1: Prepare the orisetm tissue retractor system by opening the packaging.
2. Step 2: Identify the different components of the system, including the retractor frame, blades, and locking mechanism.
3. Step 3: Attach the appropriate blades to the retractor frame, ensuring they are securely in place.
4. Step 4: Position the retractor frame over the desired area of tissue to be retracted.
5. Step 5: Engage the locking mechanism to hold the retractor in place.
6. Step 6: Adjust the tension of the retractor blades to achieve the desired level of tissue retraction.
7. Step 7: Monitor the retraction throughout the procedure and make any necessary adjustments.
8. Step 8: After the procedure, disengage the locking mechanism and remove the retractor from the surgical site.
9. Step 9: Properly clean and sterilize the orisetm tissue retractor system before reuse or disposal.

Who needs orisetm tissue retractor system?

1. The orisetm tissue retractor system is commonly used by surgeons and medical professionals during surgical procedures.
2. It is specifically designed to assist in gently retracting and holding back tissue to provide better surgical access and visualization.
3. The system is used in various surgical specialties, including general surgery, plastic surgery, gynecology, and orthopedic surgery.
4. Surgeons who perform procedures that require tissue retraction may rely on the orisetm tissue retractor system to improve surgical outcomes.

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What is orisetm tissue retractor system?

The orisetm tissue retractor system is a medical device used in surgical procedures to hold back tissue and organs.

Who is required to file orisetm tissue retractor system?

Manufacturers, distributors, and importers of medical devices are required to file orisetm tissue retractor system.

How to fill out orisetm tissue retractor system?

The orisetm tissue retractor system can be filled out online through the FDA's electronic submission portal.

What is the purpose of orisetm tissue retractor system?

The purpose of orisetm tissue retractor system is to assist in surgical procedures by providing access and visibility to the operating area.

What information must be reported on orisetm tissue retractor system?

The orisetm tissue retractor system must include information on its intended use, materials used, manufacturing process, and potential risks.