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 Advanced Surgical Concepts, 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 1 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
Cleared Aug 26, 2016
FMX314 Surgical Platform
K160797
Fortimedix Surgical B.V.
General & Plastic Surgery · 156d
Cleared Mar 17, 2016
Endo Keeper
K152598
Nelis
General & Plastic Surgery · 188d
Cleared Sep 06, 2012
ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
K121309
Advanced Surgical Concepts
General & Plastic Surgery · 128d
Cleared Aug 03, 2012
KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
K120898
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 130d
Cleared Jan 18, 2012
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
K111407
Advanced Surgical Concepts
General & Plastic Surgery · 244d
Cleared Sep 14, 2011
OCTOTMPORT
K112196
Dalim Surgnet Corporation
General & Plastic Surgery · 44d
Cleared Jan 26, 2011
ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
K110004
Advanced Surgical Concepts
General & Plastic Surgery · 23d
Cleared Nov 29, 2010
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA
K101794
Advanced Surgical Concepts
General & Plastic Surgery · 154d

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 1 in the prior period.