NumenFR E101

by MicroPort NeuroTech (Shanghai) Co., Ltd.

NumenFR E101 is a Class II device made by MicroPort NeuroTech (Shanghai) Co., Ltd., cleared under FDA 510(k) K260351 on 20 May 2026 (3 earlier submissions) and listed in FDA GUDID since 15 Mar 2022 (UDI-DI 06958698011690), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

+3 more

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK260351	Date20 May 2026Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK242154	Date30 Sep 2024Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK232955	Date10 Jan 2024Decided	StatusActive
United States	GUDID listing	Number06958698011690 UDI-DI	Date15 Mar 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK203625	Date1 Sep 2021Decided	StatusActive

Official records

AccessGUDID record UDI-DI 06958698011690
FDA 510(k) database 510(k) number K260351
FDA 510(k) database 510(k) number K242154
FDA 510(k) database 510(k) number K232955
FDA 510(k) database 510(k) number K203625

Across registries

2 registries list this device

FDA 510(k) K260351 decided 20 May 2026 Active· +3 more in the status table
FDA GUDID UDI-DI 06958698011690 listed 15 Mar 2022 Listed

Timeline

5 dated events

1 Sep 2021 Cleared FDA 510(k) K203625
15 Mar 2022 Listed FDA GUDID 06958698011690
10 Jan 2024 Cleared FDA 510(k) K232955
30 Sep 2024 Cleared FDA 510(k) K242154
20 May 2026 Cleared FDA 510(k) K260351

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: NumenFR
Generic name: Vascular implant detacher, electronic, single-use
Model / reference: E101

Primary DI / UDI-DI: 06958698011690
510(k) Number: K203625
K232955
K242154
K260351
FDA product code: HCG, KRD
GMDN term: Vascular implant detacher, electronic, single-use

Device class: Class II
Regulation number: 882.5950, 870.3300
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

Other devices from MicroPort NeuroTech (Shanghai) Co., Ltd.

See all devices from MicroPort NeuroTech (Shanghai) Co., Ltd. →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)