Definition: A Neuraxial Piston Syringe Is Intended To Inject Or Withdraw Fluid From The Neuraxial Space With Neuraxial Specific Connections. This Product Code Includes Epidural And Peripheral Administration Routes. The Connector For Neuraxial Applications Is Int
| Device Type ID | 2793 |
| Device Name | Piston Syringe With Neuraxial Connector - Epidural And Peripheral Delivery |
| Physical State | A Piston Syringe Is A Device Intended For Medical Purposes That Consists Of A Calibrated Hollow Barrel And A Movable Plunger. |
| Technical Method | A Piston Syringe Is A Device Intended For Medical Purposes That Consists Of A Calibrated Hollow Barrel And A Movable Plunger. The Connector May Be Compliant With ANSI/AAMI/ISO 80369-6: 2016: “Small Bore Connectors For Liquids And Gases In Healthcare |
| Target Area | Sites For The Neuraxial Application Include The Epidural And Peripheral Nerve Locations. |
| Regulation Description | Piston Syringe. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QEH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2793 |
| Device | Piston Syringe With Neuraxial Connector - Epidural And Peripheral Delivery |
| Product Code | QEH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Piston Syringe. |
| CFR Regulation Number | 880.5860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
JIANGSU CAINA MEDICAL CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |