OXT

Percutaneous Surgical Set With Attachments

Product code

OXT

Device name

Percutaneous Surgical Set With Attachments

Device class

Class 2

21 CFR

21 CFR 878.4805

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).