510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OTJClass II

Laparoscopic Single Port Access Device

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

OTJ is the FDA product code for Laparoscopic Single Port Access Device, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OTJ
Device name
Laparoscopic Single Port Access Device
FDA definition
A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
0

Clearances, product code OTJ

By decision year
11 clearances under product code OTJ with a decision year between 2010 and 2024, 2012 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OTJ by decision year
YearClearances
20101
20112
20123
20162
20211
20221
20241

Applicants with the most clearances

Product code OTJ
Applicants holding the most 510(k) clearances under product code OTJ
ApplicantClearances
Advanced Surgical Concepts4
Afs Medical Co., Ltd.1
Dalim Medical Corp.1
Dalim Surgnet Corporation1
Fortimedix Surgical B.V.1
Incore Co., Ltd.1
Nelis1
Richard Wolf Medical Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code