Pill Crusher/cutter

Device Code: 2712

Product Code(s): OHY

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.

Device Classification Information

Device Type ID2712
Device NamePill Crusher/cutter
Physical StateThe Device Is Aluminum/stainless Steel With A Handle, Linkage Arm, And Anvil That Are Connected To Pivot Points By Steel Pins.
Technical MethodCutting And/or Crushing.
Target AreaPill
Regulation DescriptionLiquid Medication Dispenser.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number880.6430 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeOHY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2712
DevicePill Crusher/cutter
Product CodeOHY
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionLiquid Medication Dispenser.
CFR Regulation Number880.6430 [🔎]
Device Problems
Break
1
Material Integrity Problem
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 20:17:47

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