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FDA 510(k)

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System

K-Number: K260351 · 2026-05-20

ApplicantMicroPort NeuroTech (Shanghai) Co., Ltd.
Decision Date2026-05-20
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System is the device name listed in this FDA 510(k) record. The listed applicant is MicroPort NeuroTech (Shanghai) Co., Ltd.. It received FDA 510(k) clearance on 2026-05-20 under 510(k) number K260351. 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 Numen™ Helia Coil Embolization System; NumenFR™ Detachment System?

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is MicroPort NeuroTech (Shanghai) Co., Ltd.. The 510(k) number is K260351.

When did Numen™ Helia Coil Embolization System; NumenFR™ Detachment System receive FDA 510(k) clearance?

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System received FDA 510(k) clearance on 2026-05-20, under 510(k) number K260351.

Who is the listed applicant for Numen™ Helia Coil Embolization System; NumenFR™ Detachment System?

The FDA 510(k) record lists MicroPort NeuroTech (Shanghai) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Numen™ Helia Coil Embolization System; NumenFR™ Detachment System?

The FDA product code for Numen™ Helia Coil Embolization System; NumenFR™ Detachment System is HCG.

Other records listing MicroPort NeuroTech (Shanghai) Co., Ltd. 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.

K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemK232955Numen Coil Embolization System; NumenFR Detachment SystemK203625Numen Coil Embolization System; NumenFR Detachment System

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 NeurovscularK254221Optima Coil System (OptiOne Coil System)Balt USA, LLCK252694Target Detachable CoilStryker NeurovascularK251832InZone IST Detachment System; IZDS Connecting CableStryker NeurovascularK252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC

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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