Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact