This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the sharps terminator. This device is indicated for use by individuals and healthcare professionals to safely destroy 18-27 gauge needles up to 2 inches (approx. 5 cm). The device is for use in treatment settings such as treatment rooms, emergency/trauma rooms, wards, and medication rooms of hospitals and outpatient clinics/medical offices, dental offices, and clinical laboratories.
| Device | SHARPS TERMINATOR |
| Classification Name | Sharps Needle Destruction Device |
| Generic Name | Sharps Needle Destruction Device |
| Applicant | SHARPS TERMINATOR, LLC |
| Date Received | 2012-10-23 |
| Decision Date | 2016-02-17 |
| Notice Date | 2016-03-07 |
| PMA | P120018 |
| Supplement | S |
| Product Code | MTV |
| Docket Number | 16M-0806 |
| Advisory Committee | General Hospital |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SHARPS TERMINATOR, LLC 6502 Slide Rd Suite 402 lubbock, TX 79401 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120018 | Original Filing | |
| S001 | 2017-05-25 | Normal 180 Day Track No User Fee |