FDA clears Ethicon's 1st surgical set docs can assemble inside the body | Regulatory Roundup

May 2, 2012 by MassDevice staff

The FDA grants de novo clearance to Johnson & Johnson subsidiary Ethicon Endo-Surgery's Percutaneous Surgical Set; European resolutions post-breast implant scare raise eyebrows among device makers; FDA grants PMA to Medinol's Presillion coronary stent; Nephros lands 510(k) for Hemodiafiltration; Toshiba touts FDA clearance for Aquilion Prime 80 CT system; Theragenics scores FDA clearance for Market Galt valved tearaway introducer; Spectranetics wins FDA clearance for its GlideLight laser sheath; and more.

Regulatory Roundup

Johnson & Johnson (NYSE:JNJ) Ethicon Endo-Surgery won FDA clearance for the 1st surgical instruments that can be assembled and disassembled inside the body during surgery.

Ethicon's Percutaneous Surgical Set was cleared through the federal watchdog agency' de novo pathway, a review process for low-to-moderate-risk medical devices that aren't substantially equivalent to a product already on the market.

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

The surgical set was cleared only for use during minimally invasive laparoscopic abdominal surgery, during which surgeons insert a camera and instruments through a small incision in the body.

The surgical set is the 4th device cleared under the de novo process this year, according to a press release.

JNJ shares were down 0.1% to $65.16 as of about noon today.

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