FDA 510(k) Applications for Medical Device Product Code: OTJ ()

FDA 510(k) Applications for Medical Device Product Code "OTJ"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K121309	ADVANCED SURGICAL CONCEPTS	ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE	09/06/2012
K101794	ADVANCED SURGICAL CONCEPTS	ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA	11/29/2010
K110004	ADVANCED SURGICAL CONCEPTS	ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE	01/26/2011
K111407	ADVANCED SURGICAL CONCEPTS	TRIPORT, TRIPORT+, TRIPORT15, QUADPORT	01/18/2012
K202688	AFS Medical Co. Ltd.	AFS Medical Sterile Single-Use Access Port System	10/14/2021
K112196	DALIM SURGNET CORPORATION	OCTOTMPORT	09/14/2011
K160797	Fortimedix Surgical B.V.	FMX314 Surgical Platform	08/26/2016
K220081	Incore Co., Ltd.	CORE-SPORT	09/28/2022
K152598	NELIS	Endo Keeper	03/17/2016
K120898	RICHARD WOLF MEDICAL INSTRUMENTS CORP.	KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA	08/03/2012