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FDA 510(k)

i-ED COIL System

K-Number: K210638 · 2021-03-26

ApplicantKaneka Medical America, LLC
Decision Date2021-03-26
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

i-ED COIL System is the device name listed in this FDA 510(k) record. The listed applicant is Kaneka Medical America, LLC. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K210638. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i-ED COIL System?

i-ED COIL System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Kaneka Medical America, LLC. The 510(k) number is K210638.

When did i-ED COIL System receive FDA 510(k) clearance?

i-ED COIL System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K210638.

Who is the listed applicant for i-ED COIL System?

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

What is the FDA product code for i-ED COIL System?

The FDA product code for i-ED COIL System is HCG.

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Other records listing Kaneka Medical America, LLC as applicant

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K213166Thrombuster II Aspiration Catheter

Related Devices (Code: HCG)

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.

K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFCerenovus, Inc.K261772Target Xtra Detachable CoilStryker NeurovscularK260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima Coil System (OptiOne Coil System)Balt USA, LLCK252694Target Detachable CoilStryker NeurovascularK251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular

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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