Evacuator, Bladder, Manually Operated
The Manually Operated Bladder Evacuator is a hand-powered device used to irrigate and evacuate the urinary bladder, typically following transurethral procedures to remove clots or debris. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls with no premarket notification requirement. The product code is FFD, regulated under 21 CFR 876.4370, within the Gastroenterology, Urology medical specialty.
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Basic Information
- Product Code
- FFD
- Device Class
- FDA class 1
- Regulation Number
- 876.4370
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
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 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.