# MicroPort NeuroTech (Shanghai) Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 4 (2021–2026): 4 510(k) clearances
- Product codes: HCG (4)
- 510(k) review time since 2016: median 109 days, against 49 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Neurovascular: 2 (https://510kreport.com/company/stryker-neurovascular)

## Its most-cited devices
- K232955: Numen Coil Embolization System; NumenFR Detachment System (2024), cited by 1
- K242154: Numen™ Coil Embolization System; NumenFR™ Detachment System (2024), cited by 1
- K203625: Numen Coil Embolization System; NumenFR Detachment System (2021), cited by 1

## Recent decisions
- K260351: Numen™ Helia Coil Embolization System; NumenFR™ Detachment System (May 20, 2026)
- K242154: Numen™ Coil Embolization System; NumenFR™ Detachment System (Sep 30, 2024)
- K232955: Numen Coil Embolization System; NumenFR Detachment System (Jan 10, 2024)
- K203625: Numen Coil Embolization System; NumenFR Detachment System (Sep 1, 2021)

Source page: https://510kreport.com/company/microport-neurotech-shanghai