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FDA 510(k)

OCTOTMPORT

K-Number: K112196 · 2011-09-14

ApplicantDalim Surgnet Corporation
Decision Date2011-09-14
Product CodeOTJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OCTOTMPORT is the device name listed in this FDA 510(k) record. The listed applicant is Dalim Surgnet Corporation. It received FDA 510(k) clearance on 2011-09-14 under 510(k) number K112196. 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 OCTOTMPORT?

OCTOTMPORT is a medical device that received FDA 510(k) clearance on 2011-09-14. The listed applicant is Dalim Surgnet Corporation. The 510(k) number is K112196.

When did OCTOTMPORT receive FDA 510(k) clearance?

OCTOTMPORT received FDA 510(k) clearance on 2011-09-14, under 510(k) number K112196.

Who is the listed applicant for OCTOTMPORT?

The FDA 510(k) record lists Dalim Surgnet Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCTOTMPORT?

The FDA product code for OCTOTMPORT is OTJ.

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Other records listing Dalim Surgnet Corporation 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.

K100045OCTO

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

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

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