510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OHYClass I

Pill Crusher/Cutter

21 CFR 880.6430 / General Hospital
FDA source (opens on fda.gov)

OHY is the FDA product code for Pill Crusher/Cutter, a class I device type, regulated under 21 CFR 880.6430. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OHY
Device name
Pill Crusher/Cutter
FDA 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.
Regulation
21 CFR 880.6430
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 95 companies shown, in name order