510(k) K983218
K983218 is an FDA 510(k) premarket notification submitted by Avid N.I.T., Inc. for the device "N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE". The FDA issued a decision of Substantially Equivalent on November 6, 1998. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Avid N.I.T., Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1998
- Date Received
- September 14, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biopsy Needle
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type