K202073 is an FDA 510(k) clearance for the NeedleSmart Professional (NS Pro). This device is classified as a Sharps Needle Destruction Device (Class II - Special Controls, product code MTV).
Submitted by Needlesmart Limited (Knowsley, Prescot, GB). The FDA issued a Cleared decision on March 25, 2021, 241 days after receiving the submission on July 27, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6210. A Prescription Device That Is Intended To Destroy Needles Or Sharps Used For Medical Purposes By Incineration Or Mechanical Means..
| 510(k) Number | K202073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2020 |
| Decision Date | March 25, 2021 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MTV - Sharps Needle Destruction Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6210 |
| Definition | A Prescription Device That Is Intended To Destroy Needles Or Sharps Used For Medical Purposes By Incineration Or Mechanical Means. |