Checkpoint Gemini
Handheld Single-use Surgical Bipolar Nerve Stimulator
8manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
2recalls 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 | Checkpoint Surgical Inc., United States |
|---|---|
| FDA product code | ETN |
| Device type | Stimulator, Nerve |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K092292 |
| Record published | 2022-03-30 |
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, expiry date |
| Storage | Storage environment temperature -20 to 55 °C |
| Packaging | Pouch, box, shipping carton of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9092 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212355 | 2021-08-26 |
Recalls
2 of these are Class II. 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 |
|---|---|---|---|---|
| 2025-02-24 | Class II | Process control | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confu | 135 |
| 2025-02-24 | Class II | Process control | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confu | 452 |
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.