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FDA NEWS RELEASE

For Immediate Release:  May 1, 2012
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA permits marketing of a new device for abdominal surgery

On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery.
 
The Percutaneous Surgical Set is intended to be used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one or more small incisions (surgical cuts into body tissue) in the abdomen.

Each year, more than 2 million patients undergo laparoscopic procedures in the United States. Laparoscopic surgery is a minimally invasive medical procedure that can mean shorter hospital stays, reduced recovery time and less pain for patients.

“Laparoscopic surgery reduces the size and number of incisions needed to perform certain surgical procedures,” said Christy Foreman, director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health. “The Percutaneous Surgical Set provides a novel treatment option for performing this type of abdominal procedure.”

The FDA reviewed data for the Percutaneous Surgical Set through the de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. The Percutaneous Surgical Set represents the fourth device granted a de novo petition this year.

The FDA granted the de novo petition based on data provided by the sponsor showing that the device functions as intended, and is properly sized for laparoscopic abdominal surgery, and surgeons can apply enough force to grasp and manipulate soft tissue. The sponsor also conducted studies to collect data on the ability of surgeons to assemble and disassemble the device inside the abdomen, device failures and risks, and how to address risks.

The device is indicated for use for abdominal surgery only. Risks associated with the device include device failure, user error, abdominal cavity damage, infection, and tissue inflammation.

The Percutaneous Surgical Set is manufactured by Cincinnati–based Ethicon Endo-Surgery Inc., a subsidiary of the Johnson & Johnson Co.

For more information:

FDA: Medical Devices

FDA: Device Approvals and Clearances


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 

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