DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE
FDA premarket approval P010040/S002 · decided 2003-04-04
Approval details
- PMA number
- P010040
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE
- Generic name
- Sharps needle destruction device
- Applicant
- Redhawk Medical Products & Services, LLC
- Date received
- 2003-02-24
- Decision date
- 2003-04-04
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Lafayette, LA
- Statement
- APPROVAL FOR CLINICAL USE OF THE DEVICE, THE COMPONENTS AND SHIELDING TO MINIMIZE EMI LEVELS, A HIGHER CURRENT CAPACITY FOR AC OPERATION AND TWO ADAPTERS TO ACCOMMODATE DESTRUCTION OF CONVENTIONAL NEEDLES RANGING IN SIZE FROM 5/16 TO 1 INCH IN LENGTH AND 20-30 GAUGE THAT ARE ATTACHED TO 1 TO 3 CC SYRINGES. THE DEVICE, AS MODIFIED, WHICH WILL BE MARKETED UNDER THE TRADE NAME DISINTEGRATOR PRO, IS A SHARPS NEEDLE DESTRUCTION DEVICE FOR CLINICAL USE THAT IS INDICATED FOR THE DESTRUCTION OF LANCETS
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.