Micrusframe (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);

Q: What is the product code of K262419?

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

FDA 510(k) K262419 · Cerenovus, Inc.

Substantially Equivalent

510(k) numberK262419

Submission

Device name: Micrusframe (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);
Applicant: Cerenovus, Inc.
Irvine, CA, US
Received: July 15, 2026
Decision date: August 14, 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)	Device	Applicant	Decision
K261772	Target Xtra Detachable CoilHCG · Special	Stryker Neurovscular	06/24/2026SE
K260351	Numen Helia Coil Embolization System; NumenFR Detachment SystemHCG · Special	MicroPort NeuroTech (Shanghai) Co., Ltd.	05/20/2026SE
K254221	Optima Coil System (OptiOne Coil System)HCG · Special	Balt USA, LLC	01/27/2026SE
K252694	Target Detachable CoilHCG · Traditional	Stryker Neurovascular	12/11/2025SE
K251832	InZone IST Detachment System; IZDS Connecting CableHCG · Special	Stryker Neurovascular	10/17/2025SE
K252700	Optima Coil System (Optima Packing Coil System)HCG · Special	Balt USA, LLC	09/26/2025SE
K242154	Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special	MicroPort NeuroTech (Shanghai) Co., Ltd.	09/30/2024SE
K242582	Optima Coil System (OptiBlock Line Extension)HCG · Special	Balt USA, LLC	09/27/2024SE
K242243	Target Detachable CoilsHCG · Special	Stryker Neurovscular	08/29/2024SE
K232955	Numen Coil Embolization System; NumenFR Detachment SystemHCG · Special	MicroPort NeuroTech (Shanghai) Co., Ltd.	01/10/2024SE

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

510(k)	Device	Decision
K262398	CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special	08/13/2026SE
K251828	CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetNRY · Special	08/22/2025SE
K241244	CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterQJP · Traditional	10/16/2024SE
K241221	CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus…NRY · Traditional	10/16/2024SE
K233982	CEREGLIDE 92 Catheter SystemQJP · Special	05/09/2024SE
K233988	Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetNRY · Special	01/17/2024SE
K230726	CEREGLIDE 92 Intermediate CatheterQJP · Traditional	11/29/2023SE
K221934	CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetNRY · Traditional	03/09/2023SE
K221930	CEREGLIDE 71 Intermediate CatheterQJP · Traditional	03/09/2023SE

Questions and answers

When was Micrusframe (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); cleared by the FDA?

Micrusframe (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); (K262419) received a 510(k) decision of Substantially Equivalent on August 14, 2026, 30 days after the submission was received.

What is the product code of K262419?

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