510(k) K160797

Device: FMX314 Surgical Platform
Applicant: Fortimedix Surgical B.V.
510(k) number: K160797
Product code: OTJ
Decision: Substantially Equivalent (SESE)
Decision date: 2016-08-26
Date received: 2016-03-23
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: DIRKJAN BAKKER
Address: Daelderweg 20 Nuth NL 6361 HK 6361 HK

FDA Registration Numbers#

9611102
1220351
3010370500
1418479
2219920
3020347456

Source Documents#

Other 510(k) Records For Product Code OTJ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K232062	Uni-port	Dalim Medical Corp.	2024-01-16
K220081	CORE-SPORT	Incore Co., Ltd.	2022-09-28
K202688	AFS Medical Sterile Single-Use Access Port System	Afs Medical Co. , Ltd.	2021-10-14
K152598	Endo Keeper	Nelis	2016-03-17
K121309	ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE	Advanced Surgical Concepts	2012-09-06
K120898	KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA	Richard Wolf Medical Instruments Corp.	2012-08-03
K111407	TRIPORT, TRIPORT+, TRIPORT15, QUADPORT	Advanced Surgical Concepts	2012-01-18
K112196	OCTOTMPORT	Dalim Surgnet Corporation	2011-09-14
K110004	ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE	Advanced Surgical Concepts	2011-01-26
K101794	ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA	Advanced Surgical Concepts	2010-11-29

Legacy Summary#

summary

FDA Review#

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