Premarket Approval (PMA)

Note: 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.

• Device: THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE
• Generic Name: Sharps needle destruction device
• Regulation Number: 880.6210
• Applicant: RedHawk Medical Products & Services LLC; P.O. Box 53929; Lafayette, LA 70505-3929
• PMA Number: P010040
• Date Received: 08/01/2001
• Decision Date: 03/15/2002
• Reclassified Date: 06/04/2018
• Product Code: MTV
• Docket Number: 02M-0118
• Notice Date: 03/22/2002
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE. THE DEVICE IS INDICATED FOR INSULIN NEEDLE DESTRUCTION FOR HOME USE.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002