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 Type ID | 2712 |
Device Name | Pill Crusher/cutter |
Physical State | The Device Is Aluminum/stainless Steel With A Handle, Linkage Arm, And Anvil That Are Connected To Pivot Points By Steel Pins. |
Technical Method | Cutting And/or Crushing. |
Target Area | Pill |
Regulation Description | Liquid Medication Dispenser. |
Regulation Medical Specialty | General Hospital |
Review Panel | General 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 Type | 510(K) Exempt |
CFR Regulation Number | 880.6430 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | OHY |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2712 |
Device | Pill Crusher/cutter |
Product Code | OHY |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Liquid Medication Dispenser. |
CFR Regulation Number | 880.6430 [🔎] |
Device Problems | |
---|---|
Break | 1 |
Material Integrity Problem | 1 |
Total Device Problems | 2 |