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510(k) K120898

Device
KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
510(k) number
K120898
Product code
OTJ  
Decision
Substantially Equivalent (SESE)
Decision date
2012-08-03
Date received
2012-03-26
Regulation
876.1500
Classification name
Laparoscopic Single Port Access Device
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RON HASELHORST
Address
353 Corporate Woods Pkwy. Vernon Hills IL US 60061 60061

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OTJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232062Uni-portDalim Medical Corp.2024-01-16
K220081CORE-SPORTIncore Co., Ltd.2022-09-28
K202688AFS Medical Sterile Single-Use Access Port SystemAfs Medical Co. , Ltd.2021-10-14
K160797FMX314 Surgical PlatformFortimedix Surgical B.V.2016-08-26
K152598Endo KeeperNelis2016-03-17
K121309ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts2012-09-06
K111407TRIPORT, TRIPORT+, TRIPORT15, QUADPORTAdvanced Surgical Concepts2012-01-18
K112196OCTOTMPORTDalim Surgnet Corporation2011-09-14
K110004ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts2011-01-26
K101794ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WAAdvanced Surgical Concepts2010-11-29

Legacy Summary#

summary

FDA Review#

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