Product Code: OHY FDA class 1 21 CFR 880.6430

Pill Crusher/Cutter

General Hospital

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.

510(k)s
0
FEI Numbers
92
Registration Numbers
92
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.