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: NIC 1800 NEEDLE DISPOSAL SYSTEM
• Generic Name: Sharps needle destruction device
• Regulation Number: 880.6210
• Applicant: Nic , Ltd.; 320 Fairway Dr.; Half Moon Bay, CA 94019
• PMA Number: P970036
• Date Received: 08/08/1997
• Decision Date: 09/26/1997
• Reclassified Date: 06/04/2018
• Product Code: MTV
• Docket Number: 98M-0039
• Notice Date: 01/30/1998
• Advisory Committee: General Hospital
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the NiC1800 Needle Disposal System. This device is indicated for the disposal of standard plastic syringe mounted hypodermic needles (19 gauge through 28 gauge, up to 2 inces in length) in patient treatment and clinical laboratory settings.

• Supplements: S002