FDA 510(k)

INSUFLOW SYNERGY PORT

K-Number: K120640 · 2012-07-18

Decision Date2012-07-18

Product CodeHIF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

INSUFLOW SYNERGY PORT is the device name listed in this FDA 510(k) record. The listed applicant is Lexion Medical, LLC. It received FDA 510(k) clearance on 2012-07-18 under 510(k) number K120640. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSUFLOW SYNERGY PORT?

INSUFLOW SYNERGY PORT is a medical device that received FDA 510(k) clearance on 2012-07-18. The listed applicant is Lexion Medical, LLC. The 510(k) number is K120640.

When did INSUFLOW SYNERGY PORT receive FDA 510(k) clearance?

INSUFLOW SYNERGY PORT received FDA 510(k) clearance on 2012-07-18, under 510(k) number K120640.

Who is the listed applicant for INSUFLOW SYNERGY PORT?

The FDA 510(k) record lists Lexion Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSUFLOW SYNERGY PORT?

The FDA product code for INSUFLOW SYNERGY PORT is HIF.

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Other records listing Lexion Medical, LLC as applicant

K191780AP50/30 Insufflator with Insuflow Port K170799AP 50/30 Insufflator with Insuflow Port K132203PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA K132204INSUFLOW SYNERGY XL PORT K112357VESSEL GUARDIAN K102136VESSEL GUARDIAN

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Related Devices (Code: HIF)

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KG K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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.