DeviceClearance

Product code PUR— General Hospital

Removal System Large Bore 60 cc Syringe

Classification name
Vacuum Syringe
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PUR under 21 CFR 880.5860, via openFDA

Market context for product code PUR

FDA has cleared 2 devices under product code PUR between 2017 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PUR

Recent clearances under product code PUR

Data sourced from openFDA. This site is unofficial and independent of the FDA.