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510(k) K232062

Device
Uni-port
Applicant
Dalim Medical Corp.
510(k) number
K232062
Product code
OTJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-16
Date received
2023-07-11
Regulation
876.1500
Classification name
Laparoscopic Single Port Access Device
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ji Hoon Eom
Address
102-606 And 609(Ho), 397, Seokcheon-Ro Bucheon-Si KR 14449 14449

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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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