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FDA 510(k)

ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE

K-Number: K121309 · 2012-09-06

ApplicantAdvanced Surgical Concepts
Decision Date2012-09-06
Product CodeOTJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE 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 2012-09-06 under 510(k) number K121309. 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 QUADPORT + LAPAROSCOPIC ACCESS DEVICE?

ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 2012-09-06. The listed applicant is Advanced Surgical Concepts. The 510(k) number is K121309.

When did ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE receive FDA 510(k) clearance?

ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE received FDA 510(k) clearance on 2012-09-06, under 510(k) number K121309.

Who is the listed applicant for ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE?

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 QUADPORT + LAPAROSCOPIC ACCESS DEVICE?

The FDA product code for ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE 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)K192898PneumoLinerK111407TRIPORT, TRIPORT+, TRIPORT15, QUADPORTK110004ASC 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 KeeperNelisK120898KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CARichard Wolf Medical Instruments Corp.

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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