Gyrus Acmi
Stimulator Probe POD (MCI)
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Changzhou Emanmed Biotechnology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | ETN |
| Device type | Stimulator, Nerve |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K923056 |
| Record published | 2017-05-11 |
| Record revised | 2024-09-02 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2017-06-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70921661 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 226 |
| Stimulator, Nerve | Medtronic Xomed, Inc. | 125 |
| MaXcess | Nuvasive, Inc. | 95 |
| Armada | Nuvasive, Inc. | 67 |
| Stimulator, Nerve | Neurovision Medical Products, Inc. | 47 |
| Precept | Nuvasive, Inc. | 39 |
| MAS Plif | Nuvasive, Inc. | 36 |
| NIM | Medtronic Xomed, Inc. | 34 |
| Nerveana® | Neurovision Medical Products, Inc. | 30 |
| SpheRx | Nuvasive, Inc. | 30 |
| IOM Stimulator Probes | Spes Medica Srl | 29 |
| NVM5 | Nuvasive, Inc. | 25 |
Showing 12 of 119. All products under Stimulator, Nerve
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| THE Magstim Company Ltd. | 510(k) number | 2020-12-08 | Class II | Process control | A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency includes: 1. Onboard voltage selector set | 7 units | 2023-02-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.