DeviceClearance

Product code OTJ— Gastroenterology, Urology

AFS Medical Sterile Single-Use Access Port System

Classification name
Laparoscopic Single Port Access Device
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
11
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OTJ under 21 CFR 876.1500, via openFDA

Market context for product code OTJ

FDA has cleared 11 devices under product code OTJ between 2010 and 2024, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OTJ

Recent clearances under product code OTJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.