| Device Type ID | 2683 |
| Device Name | Container, Sharps |
| Regulation Description | Hypodermic Single Lumen Needle. |
| 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 | 880.5570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MMK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2683 |
| Device | Container, Sharps |
| Product Code | MMK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hypodermic Single Lumen Needle. |
| CFR Regulation Number | 880.5570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BELLEGROVE MEDICAL SUPPLY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BRADFORD WRIGHT COMPANIES, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DANIELS SHARPSMART, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GRP & ASSOCIATES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NORTH AMERICAN RESCUE, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OAK RIDGE PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Crack | 13 |
Material Puncture / Hole | 13 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Fitting Problem | 5 |
Detachment Of Device Or Device Component | 4 |
Connection Problem | 4 |
Appropriate Term/Code Not Available | 4 |
Defective Component | 4 |
Difficult To Open Or Close | 2 |
Needle | 2 |
Mechanical Problem | 2 |
Material Protrusion / Extrusion | 2 |
Mechanical Jam | 1 |
Out-Of-Box Failure | 1 |
Incomplete Or Inadequate Connection | 1 |
Detachment Of Device Component | 1 |
Insufficient Information | 1 |
Device Unsafe To Use In Environment | 1 |
No Apparent Adverse Event | 1 |
Use Of Device Problem | 1 |
Component Missing | 1 |
Fail-Safe Problem | 1 |
Inadequate Storage | 1 |
Fail-Safe Did Not Operate | 1 |
Fracture | 1 |
| Total Device Problems | 73 |