NIM
Fuse 8250615 PAT Intfc Replcmnt KIT 32MA
8manufacturers in China registered for this device type
34catalogue numbers in this listing
10510(k) clearances naming this product code
9recalls on this code
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 | Medtronic Xomed, Inc., United States |
|---|---|
| FDA product code | ETN |
| Device type | Stimulator, Nerve |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K083124 |
| Record published | 2024-02-03 |
| Record revised | 2023-11-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -40 to 70 °C |
| Packaging | Pack of 3 |
| Sizes | Outer diameter 1 to 11.3 mm; lumen/inner diameter 6 to 11.3 mm; length 35 cm |
| Distribution end date | 2023-12-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8229506 | In distribution | ||
| 8253600 | In distribution | ||
| 8220325 | In distribution | ||
| 8250615 | In distribution | ||
| 8229307 | In distribution | ||
| 8229306 | In distribution | ||
| 8253402 | In distribution | ||
| 8229308 | In distribution | ||
| NIMDTP35 | Length 35.0 cm | In distribution | |
| 8225490X | 1mm Ball Tip | In distribution | |
| 8229307 | In distribution | ||
| 8225825X | 3 | In distribution | |
| 8229306 | In distribution | ||
| 8229508 | In distribution | ||
| 8253600 | In distribution | ||
| 8220325 | In distribution | ||
| 8225490X | Outer Diameter 1.0 mm | 3 | In distribution |
| 8225825X | In distribution | ||
| 8229308 | Outer Diameter 11.3 mm | In distribution | |
| 8220325 | In distribution | ||
| 8229307 | Lumen/Inner Diameter 7.0 mm | In distribution | |
| NIMDTP35 | In distribution | ||
| 8220325 | In distribution | ||
| 8253070 | In distribution | ||
| 8229306 | Outer Diameter 8.8 mm | In distribution | |
| 8229308 | In distribution | ||
| NIMCAD300 | In distribution | ||
| 8253075 | In distribution | ||
| 8220325 | In distribution | ||
| 8225825X | In distribution | ||
| 8229507 | In distribution | ||
| 8229308 | Lumen/Inner Diameter 11.3 mm | Withdrawn | |
| 8229307 | Outer Diameter 10.2 mm | Withdrawn | |
| 8229306 | Lumen/Inner Diameter 6.0 mm | 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 |
| Nerveana® | Neurovision Medical Products, Inc. | 30 |
| SpheRx | Nuvasive, Inc. | 30 |
| IOM Stimulator Probes | Spes Medica Srl | 29 |
| NVM5 | Nuvasive, Inc. | 25 |
| NIM TriVantage® | Medtronic Xomed, Inc. | 25 |
Showing 12 of 119. All products under Stimulator, Nerve
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251672 | 2026-02-10 |
| K230320 | 2023-10-26 |
| K231580 | 2023-08-30 |
| K213246 | 2022-03-21 |
| K112686 | 2012-06-27 |
| K063305 | 2006-11-29 |
| K050162 | 2005-03-03 |
| K031510 | 2003-06-18 |
| K031003 | 2003-04-11 |
| K014165 | 2002-01-22 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Xomed, Inc. | UDI-DI | 2022-04-29 | Class I | Under Investigation by firm | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. | 81,555 units | |
| Medtronic Xomed, Inc. | 510(k) number | 2022-04-29 | Class I | Under Investigation by firm | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. | 1,133,612 units | |
| Medtronic Xomed, Inc. | 510(k) number | 2016-06-28 | Class II | Use error | Wire in tubing can become exposed, posing potential harm to the intubated patient. | 3752 | 2019-08-07 |
| Medtronic Xomed, Inc. | 510(k) number | 2010-09-27 | Class II | Device Design | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode | 464 | 2013-11-26 |
| Medtronic Xomed, Inc. | 510(k) number | 2010-09-27 | Class II | Device Design | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode | 53 | 2013-11-26 |
| Medtronic Xomed, Inc. | 510(k) number | 2010-09-27 | Class II | Device Design | In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtronic identified a trend of open channel conditions (signal loss from the electrode). When the NIM 3.0 detects the signal loss from the electrode | 7 | 2013-11-26 |
| Medtronic Xomed, Inc. | 510(k) number | 2004-10-29 | Not classified | Other | The firm received six reports of tubes with wires ‘out of channel’ two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next c | 22569 EMG Tubes | 2012-07-07 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-11-07 | Class II | Under Investigation by firm | Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring, | 80569 units | |
| 2022-04-29 | Class I | Under Investigation by firm | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. | 23,820 units | |
| 2021-12-22 | Class II | Process control | There is potential for multiple issues due to a manufacturing nonconformity. | 301,926 devices | |
| 2013-03-04 | Class I | Use error | In March 2013, Medtronic issued a recall of the NIM TriVantage EMG Endotracheal Tube due to cuff leakage in the intraoperative cuff deflation which then requires re-inflation or replacement of the deflated tube in order to ensure the contin | 2,591 units | 2014-01-30 |
| 2008-11-21 | Not classified | Employee error | Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator. | 22 boxes (220 units) | 2009-10-01 |
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.