510(k) K926559
K926559 is an FDA 510(k) premarket notification submitted by Proact, Ltd. for the device "PROACT BIOPSY NEEDLE ENCHANCEMENTS". The FDA issued a decision of Substantially Equivalent on March 22, 1993. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Proact, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1993
- Date Received
- December 31, 1992
- 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