510(k) K941563
K941563 is an FDA 510(k) premarket notification submitted by Citation Medical Corp. for the device "THE BIOPSY TOOL". The FDA issued a decision of Substantially Equivalent on Sep 26, 1994. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Citation Medical Corp. has 11 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 26, 1994
- Date Received
- Apr 1, 1994
- 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
- 510(k)