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FDA 510(k)

TRIPORT, TRIPORT+, TRIPORT15, QUADPORT

K-Number: K111407 · 2012-01-18

ApplicantAdvanced Surgical Concepts
Decision Date2012-01-18
Product CodeOTJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRIPORT, TRIPORT+, TRIPORT15, QUADPORT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Concepts. It received FDA 510(k) clearance on 2012-01-18 under 510(k) number K111407. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIPORT, TRIPORT+, TRIPORT15, QUADPORT?

TRIPORT, TRIPORT+, TRIPORT15, QUADPORT is a medical device that received FDA 510(k) clearance on 2012-01-18. The listed applicant is Advanced Surgical Concepts. The 510(k) number is K111407.

When did TRIPORT, TRIPORT+, TRIPORT15, QUADPORT receive FDA 510(k) clearance?

TRIPORT, TRIPORT+, TRIPORT15, QUADPORT received FDA 510(k) clearance on 2012-01-18, under 510(k) number K111407.

Who is the listed applicant for TRIPORT, TRIPORT+, TRIPORT15, QUADPORT?

The FDA 510(k) record lists Advanced Surgical Concepts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIPORT, TRIPORT+, TRIPORT15, QUADPORT?

The FDA product code for TRIPORT, TRIPORT+, TRIPORT15, QUADPORT is OTJ.

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Other records listing Advanced Surgical Concepts as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232701Guardenia (GAR-1)K192898PneumoLinerK121309ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEK110004ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEK101794ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WAK073719ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE

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Related Devices (Code: OTJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232062Uni-portDalim Medical Corp.K220081CORE-SPORTIncore Co., Ltd.K202688AFS Medical Sterile Single-Use Access Port SystemAfs Medical Co. , Ltd.K160797FMX314 Surgical PlatformFortimedix Surgical B.V.K152598Endo KeeperNelisK121309ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEAdvanced Surgical Concepts

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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