Kirwan
The FDA filing identifies Kirwan’s 41-34XX disposable nerve stimulating probe series, including listed models 41-3400 and 41-3401. The probes connect to a nerve monitoring unit and deliver…
The FDA filing identifies Kirwan’s 41-34XX disposable nerve stimulating probe series, including listed models 41-3400 and 41-3401.
The probes connect to a nerve monitoring unit and deliver electrical impulses to help the user locate and identify motor nerves.
Listed Item
Bipolar Nerve Stimulator Probe, Side x Side 4″ (100mm) x 0.8mm electrodes 2m Cable with DIN42802 Connectors
Connection and Placement
The filing describes these as surface electrodes for stimulation during surgical procedures. They may contact skin or surgically exposed tissue and are not designed for insertion into tissue.
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Shenzhen Launch Electrical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | Kirwan Surgical Products, LLC., United States |
|---|---|
| FDA product code | GXZ |
| Device type | Electrode, Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1350 |
| Establishment | Manufacturer |
| 510(k) | K100912 |
| Record published | 2016-05-08 |
| Record revised | 2019-02-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5, pack of 25, pack of 50, pack of 10, pack of 4 |
| Sizes | Length 4 in; length 25 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41-3400 | Length 4 in | In distribution |
| 41-9034 | In distribution | |
| 41-9044 | In distribution | |
| 41-9036 | In distribution | |
| 41-3402 | Length 4 in | In distribution |
| 30-6023 | Length 25 cm | In distribution |
| 41-9032 | In distribution | |
| 41-9014 | In distribution | |
| 41-3401 | Length 4 in | In distribution |
| 41-9016 | In distribution | |
| 41-9022 | In distribution | |
| 41-9026 | In distribution | |
| 41-9024 | In distribution | |
| 41-9042 | In distribution | |
| 41-3403 | In distribution | |
| 41-9046 | In distribution | |
| 41-9012 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhythmlink® | Rhythmlink International, LLC | 204 |
| Technomed Europe | Technomed Engineering B.V. | 114 |
| Electrode, Needle | Medtronic Xomed, Inc. | 82 |
| Horizon™ | Rochester Electro Medical, Inc. | 68 |
| Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | 66 |
| Friendship Medical | Xi’an Friendship Medical Electronics Co., Ltd. | 66 |
| Cadwell | Technomed Engineering B.V. | 61 |
| The Electrode Store | Impulse Technology LLC | 56 |
| Horizon™ | LifeSync Corporation | 55 |
| Rochester | Rochester Electro Medical, Inc. | 41 |
| Temena | Temena GmbH | 34 |
| Cadwell | Xi’an Friendship Medical Electronics Co., Ltd. | 33 |
Showing 12 of 106. All products under Electrode, Needle
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100912 | 2010-08-19 |
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.