THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE
FDA premarket approval P010040/S001 · decided 2002-04-18
Approval details
- PMA number
- P010040
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE
- Generic name
- Sharps needle destruction device
- Applicant
- Redhawk Medical Products & Services, LLC
- Date received
- 2002-04-16
- Decision date
- 2002-04-18
- Days to decision
- 2 days
- Decision code
- APPR
- Product code
- MTV
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Lafayette, LA
- Statement
- APPROVAL FOR A CHANGE IN THE DEVICE TO ADD A PORT FOR DESTRUCTION OF LANCETS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DISINTEGRATOR PLUS NEEDLE DESTRUCTION UNIT AND IS INDICATED FOR HOME USE TO DESTROY 27 TO 30 GAUGE INSULIN HYPODERMIC NEEDLES FROM 5/16 TO = INCHES IN LENGTH, ATTACHED TO INSULIN PENS AND DISPOSABLE INSULIN SYRINGES OF 1/3 CC TO 1.0 CC VOLUME IN SIZE AND LANCETS.
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