Numen™ Helia Coil Embolization System; NumenFR™ Detachment System

FDA 510(k) K260351 · MicroPort NeuroTech (Shanghai) Co., Ltd.

Substantially Equivalent

510(k) numberK260351

Submission

Device name
Numen™ Helia Coil Embolization System; NumenFR™ Detachment System
Applicant
MicroPort NeuroTech (Shanghai) Co., Ltd.
Shanghai, CN
Received
February 3, 2026
Decision date
May 20, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HCG – Device, Neurovascular Embolization
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5950
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code HCG

510(k)DeviceApplicantDecision
K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…HCG · Special Cerenovus, Inc.08/14/2026SE
K261772Target Xtra Detachable CoilHCG · Special Stryker Neurovscular06/24/2026SE
K254221Optima Coil System (OptiOne Coil System)HCG · Special Balt USA, LLC01/27/2026SE
K252694Target Detachable CoilHCG · Traditional Stryker Neurovascular12/11/2025SE
K251832InZone IST Detachment System; IZDS Connecting CableHCG · Special Stryker Neurovascular10/17/2025SE
K252700Optima Coil System (Optima Packing Coil System)HCG · Special Balt USA, LLC09/26/2025SE
K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemHCG · Special MicroPort NeuroTech (Shanghai) Co., Ltd.09/30/2024SE
K242582Optima Coil System (OptiBlock Line Extension)HCG · Special Balt USA, LLC09/27/2024SE
K242243Target Detachable CoilsHCG · Special Stryker Neurovscular08/29/2024SE
K232955Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special MicroPort NeuroTech (Shanghai) Co., Ltd.01/10/2024SE

More from MicroPort NeuroTech (Shanghai) Co., Ltd.

510(k)DeviceDecision
K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemHCG · Special 09/30/2024SE
K232955Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special 01/10/2024SE
K203625Numen Coil Embolization System; NumenFR Detachment SystemHCG · Traditional 09/01/2021SE

Questions and answers

When was Numen™ Helia Coil Embolization System; NumenFR™ Detachment System cleared by the FDA?

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System (K260351) received a 510(k) decision of Substantially Equivalent on May 20, 2026, 106 days after the submission was received.

What is the product code of K260351?

The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.