OTJ

Laparoscopic Single Port Access Device

Product code

OTJ

Device name

Laparoscopic Single Port Access Device

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-01-16.

1 summaries are archived here for direct download.