510(k) K011270
K011270 is an FDA 510(k) premarket notification submitted by Promex, Inc. for the device "AUTOMATED CORE BIOPSY DEVICE". The FDA issued a decision of Substantially Equivalent on June 22, 2001. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Promex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2001
- Date Received
- April 26, 2001
- 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