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FDA 510(k)

ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA

K-Number: K101794 · 2010-11-29

ApplicantAdvanced Surgical Concepts
Decision Date2010-11-29
Product CodeOTJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA 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 2010-11-29 under 510(k) number K101794. 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 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA?

ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA is a medical device that received FDA 510(k) clearance on 2010-11-29. The listed applicant is Advanced Surgical Concepts. The 510(k) number is K101794.

When did ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA receive FDA 510(k) clearance?

ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA received FDA 510(k) clearance on 2010-11-29, under 510(k) number K101794.

Who is the listed applicant for ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA?

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 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA?

The FDA product code for ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA 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 DEVICEK111407TRIPORT, TRIPORT+, TRIPORT15, QUADPORTK110004ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEK073719ASC 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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