Pad, Kelly
The Kelly Pad is a device used beneath a patient during procedures to collect fluids and protect the surgical field or bedding, typically during obstetrical or urological procedures. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FNW, regulated under 21 CFR 878.4370 in the General and Plastic Surgery specialty.
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Basic Information
- Product Code
- FNW
- Device Class
- FDA class 2
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- 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 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.