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OTJ — Laparoscopic Single Port Access Device Class II

FDA Device Classification

Classification Details

Product Code
OTJ
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
SU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232062dalim medicalUni-portJanuary 16, 2024
K220081incore coCORE-SPORTSeptember 28, 2022
K202688afs medical co.AFS Medical Sterile Single-Use Access Port SystemOctober 14, 2021
K160797fortimedix surgicalFMX314 Surgical PlatformAugust 26, 2016
K152598nelisEndo KeeperMarch 17, 2016
K121309advanced surgical conceptsASC QUADPORT + LAPAROSCOPIC ACCESS DEVICESeptember 6, 2012
K120898richard wolf medical instrumentsKEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCARAugust 3, 2012
K111407advanced surgical conceptsTRIPORT, TRIPORT+, TRIPORT15, QUADPORTJanuary 18, 2012
K112196dalim surgnet corporationOCTOTMPORTSeptember 14, 2011
K110004advanced surgical conceptsASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEJanuary 26, 2011
K101794advanced surgical conceptsASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORTNovember 29, 2010