510(k) K202073
K202073 is an FDA 510(k) premarket notification submitted by Needlesmart Limited for the device "NeedleSmart Professional (NS Pro)". The FDA issued a decision of Substantially Equivalent on March 25, 2021. The device falls under product code MTV (Sharps Needle Destruction Device), a Class II device regulated under 21 CFR 880.6210.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2021
- Date Received
- July 27, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sharps Needle Destruction Device
- Device Class
- Class II
- Regulation Number
- 880.6210
- Review Panel
- HO
- Submission Type
A prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means.