Pill Crusher/Cutter
The Pill Crusher/Cutter is a device used to cut or crush solid oral medications into smaller pieces or powder form to aid in patient consumption, intended only for use with medications that are labeled as acceptable for crushing or cutting. Classified as FDA Class 1 under regulation 21 CFR 880.6430 within the General Hospital medical specialty, it is subject to general controls only and does not require a 510(k) premarket notification for marketing. The product code is OHY. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OHY
- Device Class
- FDA class 1
- Regulation Number
- 880.6430
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
A device used to cut or crush medication to aid in consumption. The device is intended to only be used with medications that are labeled as acceptable for crushing or cutting.
FEI Numbers
This FDA classification entry is associated with 92 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 92 registration numbers. Click on an entry to view related FDA registrations.