OTJ · Class II · 21 CFR 876.1500

FDA Product Code OTJ: Laparoscopic Single Port Access Device

A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery.

Leading manufacturers include Afs Medical Co. , Ltd., Incore Co., Ltd. and Dalim Medical Corp..

11
Total
11
Cleared
174d
Avg days
2010
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Laparoscopic Single Port Access Device Devices (Product Code OTJ)

11 devices
1–11 of 11
Cleared Jan 16, 2024
Uni-port
K232062
Dalim Medical Corp.
General & Plastic Surgery · 189d
Cleared Sep 28, 2022
CORE-SPORT
K220081
Incore Co., Ltd.
General & Plastic Surgery · 261d
Cleared Oct 14, 2021
AFS Medical Sterile Single-Use Access Port System
K202688
Afs Medical Co. , Ltd.
General & Plastic Surgery · 394d

About Product Code OTJ - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code OTJ since 2010, with 11 receiving FDA clearance (average review time: 174 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

OTJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →