NEEDLE ZAP (R)
FDA premarket approval P010065 · decided 2003-03-14
Approval details
- PMA number
- P010065
- Trade name
- NEEDLE ZAP (R)
- Generic name
- Sharps needle destruction device
- Applicant
- E Med Future
- Date received
- 2001-12-18
- Decision date
- 2003-03-14
- Days to decision
- 451 days
- Decision code
- APRL
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Millersburg, OH
- Statement
- APPROVAL FOR THE NEEDLEZAP. THE DEVICE IS A PORTABLE NEEDLE DESTRUCTION DEVICE THAT IS INDICATED FOR USE BY HEALTH CARE PROFESSIONALS TO DESTROY PREVIOUSLY USED ALUMINUM AND STAINLESS STEEL NEEDLES (GAUGES 16 - 30,3/4- 2 INCHES IN LENGTH) ATTACHED TO SYRINGES. THE NEEDLEZAP PRODUCT IS INTENDED FOR USE IN HEALTH CARE FACILITIES AND TREATMENT SETTINGS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.