Vacuum Syringe
The Vacuum Syringe is a general hospital device intended for use as a general-purpose syringe for injection and fluid withdrawal that can be locked in place to create a sustained vacuum for the removal of fluid and/or tissue from the body, including thrombus, abscess fluid, and infected fluid. It is classified as FDA Class II under regulation 21 CFR 880.5860, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PUR and it falls under the General Hospital medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PUR
- Device Class
- FDA class 2
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
The vacuum syringe is intended to be used as a general purpose syringe for injection and withdrawal of fluids and can be locked in place to create a vacuum for removal of fluid and/or tissue from the body in the form of thrombus, abscess fluid, and infected fluid.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.