SHARPS TERMINATOR
FDA premarket approval P120018 · decided 2016-02-17
Approval details
- PMA number
- P120018
- Trade name
- SHARPS TERMINATOR
- Generic name
- Sharps needle destruction device
- Applicant
- Sharps Terminator, LLC
- Date received
- 2012-10-23
- Decision date
- 2016-02-17
- Days to decision
- 1212 days
- Decision code
- APRL
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Lubbock, TX
- Statement
- 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.
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