FDA OKs Ethicon Endo-Surgery, Inc.'s First Surgical Set Docs Can Assemble Inside the Body
Published: May 04, 2012
The FDA grants de novo clearance to Johnson & Johnson subsidiary Ethicon Endo-Surgery's Percutaneous Surgical Set, the 1st surgical instruments that can be assembled and disassembled inside the body during surgery. 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.