Definition: A Prescription Device That Is Intended To Destroy Needles Or Sharps Used For Medical Purposes By Incineration Or Mechanical Means.
Device Type ID | 2690 |
Device Name | Sharps Needle Destruction Device |
Physical State | Sharps Needle Destruction Devices Are Typically Electrical Devices That Can Destruct Sharps And/or Needles In A Variety Of Methods (grinding, Incinerating, Etc.) That Can Be Either Portable Or Stationary. Some Of These Devices May Also Employ Soft |
Technical Method | Needles Or Sharps Are Placed Into The Device. |
Target Area | N/a |
Regulation Description | Sharps Needle Destruction Device. |
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) Infection Control Devices Branch (INCB) |
Submission Type | 510(k) |
CFR Regulation Number | 880.6210 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MTV |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2690 |
Device | Sharps Needle Destruction Device |
Product Code | MTV |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Sharps Needle Destruction Device. |
CFR Regulation Number | 880.6210 [🔎] |