OXT

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Percutaneous Surgical Set With Attachments

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4805

Medical specialty

General, Plastic Surgery

FDA definition

Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues.

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